Country: United States
Language: English
Source: NLM (National Library of Medicine)
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Apollo Health and Beauty Care Inc.
TOPICAL
OTC DRUG
to help prevent recurrence of flaking and itching associated with dandruff.
OTC monograph final
P.O.V. 2 IN 1 DRY SCALP DANDRUFF- PYRITHIONE ZINC SHAMPOO APOLLO HEALTH AND BEAUTY CARE 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 Pyrithione Zinc 1% PURPOS E Anti-dandruff US ES to help prevent recurrence of flaking and itching associated with dandruff. WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse 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._ In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. DIRECTIONS Wet hair and apply evenly to scalp, massaging gently. Rinse thoroughly. Repeat as needed. For best results, use at least twice a week or as directed by a doctor. INACTIVE INGREDIENTS Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Cocamidopropyl Betaine, Acrylates Copolymer, Laureth-4, Fragrance (Parfum), Dimethicone, Cocamide MEA, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone. QUESTIONS OR COMMENTS? 1-866-695-3030 LABEL COPY P.O.V. 2 IN 1 DRY SCALP DANDRUFF pyrithione zinc shampoo PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 3148 -410 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY Apollo Health and Beauty Care Inc. INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5) PYRITHIONE ZINC 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 ) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) GLYCO L DISTEARATE (UNII: 13W7MDN21W) CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX) METHACRYLIC ACID - METHYL ME Read the complete document