CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL- 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 USIGN THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

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), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, CHROMIUM HYDROXIDE GREEN (CI 77289), RED 4 (CI 14700), RED 33 (CI 17200), CARAMEL.

IMAGE OF THE LABEL

CARE ONE  ANTIBACTERIAL PEPPERMINT SWIRL
ethyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-472
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SULISOBENZONE (UNII: 1W6L629B4K)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-472-02 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 09/27/2012
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(41520-472)

Revised: 9/2012
Document Id: d3ea9052-d071-485a-8aca-998e42896582
Set id: 884631aa-f940-458f-a187-537eab5ed59d
Version: 1
Effective Time: 20120927
 
AMERICAN SALES COMPANY