CAREONE VANILLA BUTTERCREAM HAND SANITIZER- ethyl alcohol liquid

Careone Vanilla Buttercream Hand Sanitizer by

Drug Labeling and Warnings

Careone Vanilla Buttercream Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

• helps 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 eyes thoroughly with water.

Stop using this product 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

• wet hands thoroughly and rub together until dry.

Other information

store at a temperature below 110°F (43°C)

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Red 33 (CI 17200), Yellow 5 (CI 19140).

Label Copy

INGREDIENTS AND APPEARANCE

CAREONE VANILLA BUTTERCREAM HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-058
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-058-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/25/2017
2	NDC: 41520-058-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/25/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/25/2017

Labeler - American Sales Company (809183973)

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

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(41520-058)