Label: XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS- pyrithione zinc lotion/shampoo
- NDC Code(s): 58503-027-01
- Packager: China Ningbo Shangge Cosmetic Technology Corp.
- Category: HUMAN OTC DRUG LABEL
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, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 20 mg in 400 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) CETYL ALCOHOL (UNII: 936JST6JCN) POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU) DMDM HYDANTOIN (UNII: BYR0546TOW) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) TRIDECETH-6 (UNII: 3T5PCR2H0C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) SHEA BUTTER (UNII: K49155WL9Y) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-027-01 400 mg in 1 BOTTLE; Type 0: Not a Combination Product 10/09/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/09/2013 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-027)