HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Use as hand sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

STOP USE

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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, purified water USP, hydroxyethylcellulose

Package Label - Principal Display Panel

3780 mL NDC: 74100-002-01

18930 mL NDC: 74100-002-05

208197648 mL NDC: 74100-002-55

124918530 mL NDC: 74100-002-33

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74100-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.325 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)	0.375 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.0028 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74100-002-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	05/08/2020
2	NDC: 74100-002-05	18930 mL in 1 JUG; Type 0: Not a Combination Product	05/08/2020
3	NDC: 74100-002-55	208197648 mL in 1 DRUM; Type 0: Not a Combination Product	05/08/2020
4	NDC: 74100-002-33	1249185300 mL in 1 TANK; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Gemini Industries Inc. (007207129)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Industries Inc.		007207129	manufacture(74100-002)