RITE AID RENEWAL MEDICATED- selenium sulfide liquid 
RITE AID CORPORATION

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

ANTI-DANDRUFF, ANTI-SEBORREIC DERMATITIS

USES

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RECURRENCE.

WARNINGS

FOR EXTERNAL USE ONLY.

ASK A DOCTOR BEFORE USING IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.

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.

QUESTIONS/COMMENTS?

1-866-695-3030

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, ACRYLATES COPOLYMER, TEA-LAURETH SULFATE, COCAMIDOPROPYL BETAINE, CITRIC ACID, AMMONIUM CHLORIDE, FRAGRANCE (PARFUM), DMDM HYDANTOIN, SODIUM HYDROXIDE, MENTHOL, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200).

LABEL COPY

IMAGE OF THE LABEL

RITE AID RENEWAL  MEDICATED
selenium sulfide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6201
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)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MENTHOL (UNII: L7T10EIP3A)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-6201-1 325 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 - RITE AID CORPORATION (014578892)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(11822-6201)

Revised: 7/2013
Document Id: 344d4216-82a8-4e87-adde-d2972cc481e9
Set id: c5a7f1c9-42ac-4eef-8a40-da338329731c
Version: 1
Effective Time: 20130715
 
RITE AID CORPORATION