CARE ONE ANTIBACTERIAL TANGERINE SPICE- 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

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 ANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110F (43C).

INACTIVE INGREDIENTS:

WATER (AQUA), pROPYLENE GLYCOL, CARBOMER, GLYCERIN, ISOPROPYL MYRISTATE, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, TRIETHYL CITRATE, MICA, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, TALC, TITANIUM DIOXIDE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), RED 4 (CI 14700), ORANGE 4 (CI 15510).

IMAGE OF THE LABEL

CARE ONE  ANTIBACTERIAL TANGERINE SPICE
ethyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-470
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER 934 (UNII: Z135WT9208)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
MICA (UNII: V8A1AW0880)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-470-02 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 09/25/2012
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(41520-470)

Revised: 9/2012
Document Id: 5844de03-3961-49b5-b991-550e4e617390
Set id: 8f750839-bcb9-499c-8a61-ea8c4a0d296d
Version: 1
Effective Time: 20120926
 
AMERICAN SALES COMPANY