Label: ANTI DANDRUFF- salicylic acid shampoo
- NDC Code(s): 71331-106-09, 71331-106-33
- Packager: Orange Lab
- 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 January 31, 2023
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- Active Ingredient
- Warnings
- Purpose
- PREGNANCY OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Inactive Ingredients
- Directions
- Shampoo description
- Directions
- OTC Active Ingredient
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
ANTI DANDRUFF
salicylic acid shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71331-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) MENTHOL (UNII: L7T10EIP3A) C12-16 PARETH-9 (UNII: 9DJ758090Y) DEHYDROACETIC ACID (UNII: 2KAG279R6R) TRIDECETH-12 (UNII: YFY3KG5Y7O) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) WATER (UNII: 059QF0KO0R) ASIAN GINSENG (UNII: CUQ3A77YXI) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) NIACINAMIDE (UNII: 25X51I8RD4) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J) PROPOLIS WAX (UNII: 6Y8XYV2NOF) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) GLYCOL STEARATE (UNII: 0324G66D0E) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) PAULLINIA CUPANA SEED (UNII: C21GE7524R) BENZOIC ACID (UNII: 8SKN0B0MIM) C11-15 PARETH-7 (UNII: 261HPE0IS3) Product Characteristics Color white (Pearly White/Yellowish color) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71331-106-09 237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2020 2 NDC:71331-106-33 946 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 01/01/2020 Labeler - Orange Lab (004862271) Registrant - Orange Lab (004862271) Establishment Name Address ID/FEI Business Operations Orange Lab 004862271 manufacture(71331-106)
