EQUALINE CLINICAL STRENGTH- selenium sulfide liquid 
SUPERVALU INC.

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.

----------

DRUG FACTS

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

USES

HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS.

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 EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

STOP USING THIS PRODUCT 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

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

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

INACTIVE INGREDIENTS

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, ACRYLATES COPOLYMER, AMMONIUM XYLENESULFONATE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700).

QUESTIONS OR COMMENTS?

1-877-932-7948

LABEL COPY

IMAGE OF THE LABEL

EQUALINE  CLINICAL STRENGTH
selenium sulfide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-618
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)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-618-14 420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 02/14/2013
Labeler - SUPERVALU INC. (006961411)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41163-618)

Revised: 2/2013
Document Id: 990ce740-8c8f-40bd-aa96-6d60a1eff961
Set id: 1e03fd8b-c18f-43c3-9527-8746f5abddc5
Version: 1
Effective Time: 20130214
 
SUPERVALU INC.