TOPCARE PREBIOTIC HAND SANITIZER- ethyl alcohol liquid

TopCare Prebiotic Hand Sanitizer by

Drug Labeling and Warnings

TopCare Prebiotic 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 65%

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 hands 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, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

Label copy

INGREDIENTS AND APPEARANCE

TOPCARE PREBIOTIC HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-996
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)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER 934 (UNII: Z135WT9208)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-996-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2019
2	NDC: 36800-996-02	59 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(36800-996)