Country: United States
Language: English
Source: NLM (National Library of Medicine)
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B)
AMERICAN SALES COMPANY
TOPICAL
OTC DRUG
ANTI-DANDRUFF FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE.
OTC monograph final
MEDICATED DANDRUFF - SELENIUM SULFIDE SHAMPOO 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._ ---------- DRUG FACTS ACTIVE INGREDIENT SELENIUM SULFIDE 1% PURPOSE ANTI-DANDRUFF USES FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE. 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? 1-866-690-3030 INACTIVE INGREDIENTS WATER (AQUA), AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1, RED 33, SODIUM CITRATE, SODIUM CHLORIDE FRONT AND BACK LABELS MEDICATED DANDRUFF selenium sulfide shampoo PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:41520 -6 14 ROUTE OF ADMINISTRATION TOPICAL AMERICAN SALES COMPANY ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SELENIUM SULFIDE (UNII: Z6 9 D9 E38 1Q) (SELENIUM - UNII:H6 241UJ22B) SELENIUM SULFIDE 1 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) AMMO NIUM LAURYL SULFATE (UNII: Q7AO2R1M0 B) TRO LAMINE LAURYL SULFATE (UNII: E8 458 C1KAA) CO CAMIDO PRO PYL BETAINE (UN Read the complete document