Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 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 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

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 below 110F (43C)

Inactive ingredients

Purified water USP, Aloe Barbadensis, acrylates/C10-30 alkyl acrylate crosspolymer, Propylene Glycol, PEG-8 Dimethicone, Triisopropanolamine, Linalool, FD&C #1

Amerigel Hand Sanitizer 6 oz

Amerigel

Amerigel Hand Sanitizer 16 oz

Amerx Hand Sanitizer 16 oz

AMERIGEL HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79417-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	28.397 L in 100 L
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 L in 100 L
LINALOOL, (+/-)- (UNII: D81QY6I88E)	0.07 L in 100 L
CARBOMER 1342 (UNII: 809Y72KV36)	0.27 L in 100 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 L in 100 L
PEG-8 DIMETHICONE (UNII: GIA7T764OD)	0.3 L in 100 L
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)	0.41 L in 100 L
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.003 L in 100 L

Product Characteristics
Color	blue (Translucent Gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79417-010-06	0.177 L in 1 TUBE; Type 0: Not a Combination Product	07/02/2020
2	NDC:79417-010-16	0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/02/2020

Labeler - Kova Laboratories, Inc. (193055027)

Registrant - Kova Laboratories, Inc. (193055027)

Name	Address	ID/FEI	Business Operations
Establishment
Kova Laboratories, Inc.		193055027	label(79417-010) , manufacture(79417-010)