CARE ONE SUN KISSED PEAR- 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 DEA Schedule     
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)  
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-474-02 59 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/14/2013
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-474)

Revised: 2/2013
Document Id: f30495a7-6931-46ce-b3c6-af50de8352b2
Set id: 88e34906-647e-4554-b27d-e077d49806a9
Version: 1
Effective Time: 20130214
 
AMERICAN SALES COMPANY