CARE ONE MOISTURIZING- selenium sulfide 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

SELENIUM SULFIDE 1%

PURPOSE

ANTIDANDRUFF

USE

CONTROLS FLAKING, SCALING AND ITCHING ASSOCIATED WITH DANDRUFF.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE

ON SCALP THAT IS BROKEN OR INFLAMED, IF YOU ARE ALLERGIC TO INGREDIENTS IN THIS PRODUCT.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

SHAKE WELL. SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, DISTEARYL PHTHALIC ACID AMIDE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, DIMETHICONE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE (PARFUM), SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE, BLUE 1 (CI 42090).

QUESTIONS/COMMENTS?

1-866-695-3030

LABEL COPY

IMAGE OF THE LABEL

CARE ONE  MOISTURIZING
selenium sulfide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-621
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-621-11 325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 07/15/2013
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(41520-621)

Revised: 7/2013
Document Id: 2ac8a2a1-3a9b-4e8d-8124-5f8dd7cfb96c
Set id: 59ed1650-5950-446a-b1a1-2d0df92f976f
Version: 1
Effective Time: 20130715
 
AMERICAN SALES COMPANY