GUARD HAND SANITIZER- ethyl alcohol gel

Guard Hand Sanitizer by

Drug Labeling and Warnings

Guard Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin . For use when soap and water are not available.

Warnings 

For external use only

• flammable
• keep away from source of heat or fire

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use

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

Stop use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• put enough product in your palm to cover hands and rub hands together for at least 30 seconds. Allow to dry.
• children under 6 years should be supervised when using this product.

Other information

• store at a temperature below 110°F (43°C)
• may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

1-866-695-3030

Label copy

INGREDIENTS AND APPEARANCE

GUARD HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-515-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
2	NDC: 63148-515-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
3	NDC: 63148-515-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/17/2020

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-515)