CARE ONE SUN KISSED PEAR- 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 USING THIS PRODUCT AND ASK 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 110F (43C).

INACTIVE INGREDIENTS:

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, TOCOPHERYL ACETATE, RETINYL PALMITATE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

LABEL COPY

IMAGE OF THE LABEL

CARE ONE SUN KISSED PEAR
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-474
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)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SULISOBENZONE (UNII: 1W6L629B4K)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-474-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/14/2013

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(41520-474)