Label: OARS AND ALPS PURIFYING SCALP SCRUB- salicylic acid gel

  • 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 November 10, 2022

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  • ACTIVE INGREDIENT

    Salicylic Acid – 2%

  • PURPOSE

    Anti-Dandruff

  • Uses

    • Controls the symptoms of dandruff
  • WARNINGS

    ​For external use only.

    Ask a doctor before use if you have a condition that covers a large area of the body

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a docto r if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply directly to the scalp while your hair is dry.
    • Massage into scalp with fingertips.
    • Rinse thoroughly, then shampoo and condition as you normally would
    • Use 3 days a week or as needed.
  • INACTIVE INGREDIENT

    Apple Cider Vinegar, Caffeine, Caramel, Citric Acid, Cladonia Stellaris Extract, Creatine, Dehydroxanthan Gum, Fragrance, Glycerin, Hydroxypropyl Starch Phosphate, Iron Oxides, Jojoba Esters, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Perlite, Potassium Sorbate, Propanediol , Sodium Benzoate, Sodium Cocoyl Glutamate, Sodium Gluconate, Sorbitan Oleate Decylglucoside Crosspolymer, Sucrose, Water

  • QUESTIONS

    Contact Hi@oarsandalps.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    OARS AND ALPS PURIFYING SCALP SCRUB 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83046-364
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    MELALEUCA ERICIFOLIA LEAF OIL (UNII: 7V77E85X7B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PERLITE (UNII: 0SG101ZGK9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    SUCROSE (UNII: C151H8M554)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CARAMEL (UNII: T9D99G2B1R)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CREATINE (UNII: MU72812GK0)  
    CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    DISTARCH PHOSPHATE, CORN (UNII: JFB4DJZ8BR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83046-364-81118 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03212/01/2021
    Labeler - Oars and Alps LLC (040241941)
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