Chap-et: Package Insert and Label Information

CHAP-ET- petrolatum lipstick
Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts — Regular

Active ingredient

White petrolatum 61.93%

Purpose

Skin protectant

Use

  • helps prevent, temporarily protects and helps relieve chafed, chapped or cracked lips
  • helps prevent and protect lips from the drying effects of wind and cold weather

Warnings

  • When using this product do not get into eyes

Stop use and ask a doctor if

  • condition worsens

  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If more than used for lip protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Other information

store at room temperature

Inactive ingredients

camphor, hydrogenated vegetable oil, iron oxides, isopropyl myristate, lecithin, mineral oil, wax

Questions?

call toll-free 1-866-255-5202 weekdays


Drug Facts — Cherry

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavors, red 27 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Bubble Gum

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavors, saccharin, red 27 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Mint

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavor, blue 2 lake, yellow 10 lake, blue 1 lake, lecithin, hydrogenated vegetable oil, saccharin

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

Drug Facts – Vanilla

Active ingredient

White petrolatum 61.93% w/w

Use

helps prevent, protect and relieve chapped lips

Warnings

For external use only.

Stop use and ask a doctor if

condition last more than 7 days

Directions

apply as needed

Inactive ingredients

wax, isopropyl myristate, mineral oil, flavor, saccharin, iron oxides, yellow 10 lake, lecithin, hydrogenated vegetable oil

Questions?

1-866-255-5202

Sealed Twist-Off Cap
Do Not Use If Seal Is Broken

PRINCIPAL DISPLAY PANEL

Regular chap-et
LIP BALM SKIN PROTECTANTNET WT 0.16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL
Regular chap-et
LIP BALM SKIN PROTECTANT
NET WT 0.16 OZ (4.5g)
(click image for full-size original)


PRINCIPAL DISPLAY PANEL

Cherry chap-et
LIP BALM SKIN PROTECTANTNET WT 0.16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL
Cherry chap-et
LIP BALM SKIN PROTECTANT
NET WT 0.16 OZ (4.5g)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Bubble Gum chap-et
LIP BALM SKIN PROTECTANTNET WT 0.16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL
Bubble Gum chap-et
LIP BALM SKIN PROTECTANT
NET WT 0.16 OZ (4.5g)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Mint chap-et
LIP BALM SKIN PROTECTANTNET WT 0.16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL
Mint chap-et
LIP BALM SKIN PROTECTANT
NET WT 0.16 OZ (4.5g)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Vanilla chap-et
LIP BALM SKIN PROTECTANTNET WT 0.16 OZ (4.5g)

PRINCIPAL DISPLAY PANEL
Vanilla chap-et
LIP BALM SKIN PROTECTANT
NET WT 0.16 OZ (4.5g)
(click image for full-size original)
CHAP-ET white petrolatum lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-411
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 619.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)
CORN OIL
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-411-01 1 TUBE in 1 CARTON contains a TUBE
1 4.5 g in 1 TUBE This package is contained within the CARTON (63029-411-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/01/2012 10/31/2022
CHAP-ET white petrolatum lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-422
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 619.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27
CORN OIL
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
MINERAL OIL
ALUMINUM OXIDE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-422-02 4.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/01/2012 10/31/2022
CHAP-ET white petrolatum lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-444
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 619.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27
CORN OIL
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
MINERAL OIL
ALUMINUM OXIDE
SACCHARIN
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-444-02 4.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/01/2012 10/31/2022
CHAP-ET white petrolatum lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-433
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 619.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
CORN OIL
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
MINERAL OIL
ALUMINUM OXIDE
SACCHARIN
FD&C BLUE NO. 2
D&C YELLOW NO. 10
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-433-01 4.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/01/2012 10/31/2022
CHAP-ET white petrolatum lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-455
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 619.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CORN OIL
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
MINERAL OIL
ALUMINUM OXIDE
SACCHARIN
D&C YELLOW NO. 10
Product Characteristics
Color Score
Shape Size
Flavor VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-455-01 4.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/01/2012 10/31/2022
Labeler — Medtech Products Inc. (122715688)

Revised: 06/2020 Medtech Products Inc.

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