INSTANT HAND SANITIZER: Package Insert and Label Information

INSTANT HAND SANITIZER — hand sanitizer
NINGBO CLEANER DAILY USED PRODUCTS CO. LTD.

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

Active Ingredients

Ethyl Alcohol 62%

Purpose


Antiseptic

Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Uses

hand sanitizer to help decrease bacteria on the skin. when water, soap and towel are not available. recommended for repeated use

Warnings

  • For external use only
  • Flammable
  • Keep away from fire or flame

Do not apply around eyes. Do not use in ears and mouth.

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

pump as needed into your palms and thoroughly spread on both hands. rub skin until dry.

Other information

store at 20 degree celsius (68 degrees to 77 degrees fahrenheit). may discolor fabrics.

Inactive ingredients

water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance

Package Label

Hand Sanitizer
(click image for full-size original)

INSTANT HAND SANITIZER hand sanitizer kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:18018-501
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:18018-501-34 1 KIT (KIT) in 1 PACKAGE, COMBINATION None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 POUCH 1000 mL
Part 2 1 BOTTLE, PUMP 237 mL
Part 1 of 2
INSTANT HAND SANITIZER hand sanitizer gel
Product Information
Item Code (Source) NDC:18018-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
ALPHA-TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 1000 mL in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 11/01/2009
Part 2 of 2
INSTANT HAND SANITIZER hand sanitizer gel
Product Information
Item Code (Source) NDC:18018-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
ALPHA-TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 237 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 11/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 11/01/2009
Labeler — NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. (527983808)
Establishment
Name Address ID/FEI Operations
NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. 527983808 manufacture

Revised: 11/2009 NINGBO CLEANER DAILY USED PRODUCTS CO. LTD.

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