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
SHOPKO BEAUTY CLASSIC SPICE 2 IN 1 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 eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not imrove 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 for best results, use at least twice a week or as directed by a doctor. wet hair, massage onto scalp and rinse. repeat if desired. INACTIVE INGREDIENTS Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamide MEA, Glycol Distearate, Dimethicone, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Fragrance (Parfum), Laureth- 4, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200). QUESTIONS OR COMMENTS? 1-866-695-3030 LABEL COPY SHOPKO BEAUTY CLASSIC SPICE 2 IN 1 DANDRUFF pyrithione zinc shampoo PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 3148 -0 0 3 ROUTE OF ADMINISTRATION TOPICAL Apollo Health and Beauty Care Inc. ACTIVE INGREDIENT/ACTIVE MOIETY 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) CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D) GLYCO L DISTEAR Read the complete document