CUPCAKE- ethyl alcohol liquid

Cupcake by

Drug Labeling and Warnings

Cupcake by is a Otc medication manufactured, distributed, or labeled by Huijing (Shanghai) Bio-tech Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

carbomer 940, PEG-12

dimethicone, red-33, tocopheryl

acetate, triethanomaline,

water

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol, 65 % v/v

PURPOSE

Purpose  Antimicrobial

INDICATIONS & USAGE

Uses

hand sanitizer to help

reduce bacteria on skin

DO NOT USE

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

STOP USE

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Put a dime sized drop onto hands

and rub together briskly until dry.

STORAGE AND HANDLING

Other information

Store below 110 F (43 C)

WARNINGS

Warning

For external use only

Flammable, keep away from fire or flame.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CUPCAKE  
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71537-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71537-002-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2017

Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337)

Establishment
Name	Address	ID/FEI	Business Operations
Huijing (Shanghai) Bio-tech Co., Ltd		544482337	manufacture(71537-002)