Label: PUR 4-IN-1 CORRECTING PRIMER- salicylic acid emulsion

  • NDC Code(s): 67345-0380-1, 67345-0380-2, 67345-0380-3
  • Packager: Purminerals
  • 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 3, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Salicylic Acid 1.0% w/w Purpose: Acne Medicaiton

    Acne Medication

  • Uses

    • For the treatment of acne
  • Warnings

      For external use only

    • Keep out of reach of children.  If swallowed, call a Poison Control Center or get medical help right away
    • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time.  If irritation occurs, rinse thoroughly with water
    • Avoid contact with eyes.   If contact occurs, rinse thoroughly with water.
    • For more severe cases, or if improvement is not apparent within 6-8 weeks, consult a health care professional.

    ​Know Adverse Reaction(s):​ If you develop severe irritation, burning or itching of the skin, discontinue use and consult a health care professional.

    • if you develop hives, swelling of the eyes and mouth, blistering or difficulty breathing, get medical help right away.

    When using this product

    • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, rinse thoroughly with water
      Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Keep out of reach of children.

    Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away

  • Directions

    • Clean the skin thoroughly before applying the product

    ​For New Users

    • Apply product to a small area once a day for three days to test if you are sensitive to this product, if not discomfort occurs, cover the entire affected area with a thin layer
    • Start with one application daily, the gradually increase to two or three times daily if needed.
    • If dryness or peeling occurs, reduce application to once a day or every other day.
    • Keep carton fo additional directions and warning information
  • Inactive Ingredients

    Alteromonas Ferment Filtrate, Buddleja Officinalis Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter) Extract, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Ceramide AP, Charcoal Powder, Citric Acid, Decyl Glucoside, Dimethicone, Glycerin, Hexylene Glycol, Hydroxyethylcellulose, L-Lactic Acid, Niacinamide, Panax Ginseng Root Extract, Pentylene Glycol, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polymethylsilsesquioxane, Polysilicone-11, Polysorbate 20, Potassium Sorbate, Propanediol, Retinol, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Water

  • PRINCIPAL DISPLAY PANEL

    acneprimer

  • INGREDIENTS AND APPEARANCE
    PUR 4-IN-1 CORRECTING PRIMER 
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0380
    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
    ALTEROMONAS MACLEODII (UNII: BPX036043D)  
    BUDDLEJA OFFICINALIS FLOWER (UNII: 274707Y672)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LACTIC ACID, L- (UNII: F9S9FFU82N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    RETINOL (UNII: G2SH0XKK91)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0380-21 in 1 CARTON01/01/2020
    1NDC:67345-0380-130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67345-0380-310 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00601/01/2020
    Labeler - Purminerals (114450443)