Hand Sanitizer Ethyl Alcohol 62%

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gabe, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Gabe, 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.

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Hand Sanitizer Ethyl Alcohol 62%

Purpose

Antiseptic, Hand Sanitizer

Drug Facts

.

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Uses

■ Hand sanitizer to help reduce germs on the skin that can potentially cause disease. ■ Recommended for repeated use.

Warnings

■ For external use only.
■ Flammable: Keep away from fire or flame.

When using this product ■ Keep out of eyes. In case of eye contact, flush eyes with water. ■ Avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

Directions

■ Wet hands thoroughly with product. ■ Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.

■ Allow to dry without wiping.

Inactive ingredients

Aloe Vera, FD&C Blue #1, FD&C Yellow #5, Fragrance, PEG/PPG18/18 Dimethicone, Tocopheryl Acetate, Water

Questions or comments?

1-855-385-8555

Package Label - Principal Display Panel

118.3 mL NDC: 81218-1000-1

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81218-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81218-1000-1	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2021	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/25/2021	01/01/2022

Labeler - Gabe, Inc. (784151438)

Revised: 11/2022

Document Id: ecae9f7b-41f6-7930-e053-2995a90aff67

34390-5

Set id: beba1e25-2c9f-7a4f-e053-2995a90a1d41

Version: 2

Effective Time: 20221104

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