Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
LibertyWare LLC

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.

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

for handwashing to decrease bacteria on the skin.

Recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in the eyes. In case of contact rinse eyes thoroughly with water.

In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply products to hands
  • Briskly rub hands together until dry
  • Supervise children under 6 years in the use of this product

Other information

  • Store below 100F (43C)
  • May discolor certain fabrics

Inactive ingredients

distilled water, glycerin, rosemary, basil oil, aloe vera, vitamin e, azadirachtae indicae oil, essential oil, carbomer 940, tween 20

Package Label — Principal Display Panel

250 mL NDC: 90076-100-01

90076-100-01
(click image for full-size original)

1000 mL NDC: 90076-100-02

90076-100-02
(click image for full-size original)

5L NDC: 90076-100-03

90076-100-03
(click image for full-size original)
HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:90076-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF 1 mL in 100 mL
GLYCERIN 1.45 mL in 100 mL
ROSEMARY 1.45 mL in 100 mL
WATER 22.5 mL in 100 mL
BASIL OIL 1.45 mL in 100 mL
.ALPHA.-TOCOPHEROL 0.6 mL in 100 mL
AZADIRACHTA INDICA SEED OIL 0.5 mL in 100 mL
CARBOMER 940 0.4 mL in 100 mL
POLYSORBATE 20 0.1 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:90076-100-01 250 mL in 1 BOTTLE None
2 NDC:90076-100-02 1000 mL in 1 BOTTLE None
3 NDC:90076-100-03 5000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — LibertyWare LLC (949700595)
Registrant — LibertyWare LLC (949700595)
Establishment
Name Address ID/FEI Operations
LibertyWare LLC 949700595 manufacture (90076-100)

Revised: 10/2020 LibertyWare LLC

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