CARE ONE LEMON VERBENA- 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

WET HANDS THOROUGHLY AND RUN TOGETHER UNTIL DRY.

OTHER INFORMATION

STORE AT A TEMPERTAURE BELOW 110F (43C)

INACTIVE INGREDIENTS:

WATER (AQUA), CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

LABEL COPY

IMAGE OF THE LABEL

CARE ONE  LEMON VERBENA
ethyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-479
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-479-02 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(41520-479)

Revised: 2/2013
Document Id: 8b9ae1fb-9a3a-460c-88b0-575803eb5648
Set id: 5ee89a4a-d0de-4a4e-a804-fc0717648c2b
Version: 1
Effective Time: 20130214
 
AMERICAN SALES COMPANY