Label: CLASSIC CONTROL- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 71141-026-04 - Packager: LIDL US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated September 12, 2022
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INGREDIENTS AND APPEARANCE
CLASSIC CONTROL
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71141-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) LAURETH-4 (UNII: 6HQ855798J) EDETATE SODIUM (UNII: MP1J8420LU) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71141-026-04 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/12/2021 Labeler - LIDL US LLC (079389709) Registrant - Apollo Health and Beauty Care (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care 201901209 manufacture(71141-026)