TOPCARE ADVANCED HAND SANITIZER VITAMIN E- ethyl alcohol liquid

TopCare Advanced Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin

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.

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. 1-800-222-1222

Directions

• put enough hand sanitizer in your palm to cover hands and rub hand together until 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, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Propylene Glycol, Aminomethyl Propanol, Fragrance (Parfum).

Label copy

INGREDIENTS AND APPEARANCE

TOPCARE ADVANCED HAND SANITIZER  VITAMIN E
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-992
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-992-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2019
2	NDC: 36800-992-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2019
3	NDC: 36800-992-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/20/2019

Labeler - TopCo Associates LLC (006935977)

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

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(36800-992)