CAREONE ANTIBACTERIAL SANITIZER GINGERBREAD HOUSE- ethyl alcohol liquid
AMERICAN SALES COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

ETHYL ALCOHOL 65%

PURPOSE

ANTISEPTIC

USES

TO DECREASE 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 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

DIRECTIONS

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY
CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

INACTIVE INGREDIENTS

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491, CI 77492, CI 77499), ORANGE 4 (CI 15510)

LABEL COPY

IMAGE OF THE LABEL

CAREONE ANTIBACTERIAL SANITIZER GINGERBREAD HOUSE
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-414
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SULISOBENZONE (UNII: 1W6L629B4K)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-414-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/22/2015

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-414)