Label: ANTIAC ACNE CLEARING- salicylic acid spray

  • 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 July 24, 2013

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

  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps clear acne blemishes, acne pimples, blackheads, and
      whiteheads
  • Warnings

    For external use only

  • When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at thesame time. If irritation occurs, only use one topical acne medication at a time.
    • Not to be used for children under three years of age
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well before use
    • Spray directly onto affected area
    • Soak a cotton pad and thoroughly wipe affected area
    • Because excessive drying of the skin may occur, start with one
      application daily, then gradually increase to two or three times daily
      if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive ingredients

    Purified Water (Aqua), Alcohol Denat, Glycerin (Vegetable), Sunflower (Helianthus
    Annuus) Seed Oil, Glyceryl Cocoate, Hydrogenated Coconut Oil, Safflower
    (Carthamus Tinctorius) Seed Oil, Isononyl Isononanoate, Sodium Cetearyl Sulfate,
    Cetearyl Glucoside, Cetearyl Alcohol, Grape (Vitis Vinifera) Seed Oil,
    Phenoxyethanol, Ethylhexylglycerin, Salicylic Acid, CI 75130, Sea Buckthorn
    (Hippophae Rhamnoides) Kernel Extract, Rosemary (Rosmarinus Officinalis) Leaf
    Extract, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Trideceth-9,
    Sandalwood (Santalum Album) Oil, Tea Tree (Melaleuca Alternifolia) Leaf Oil,
    Ceteareth-25, Orange (Citrus Aurantium Dulcis) Peel Oil, Dead Sea Salt (Maris Sal),
    Eucalyptus (Eucalyptus Globulus) Leaf Oil, Manuka (Leptospermum Scoparium)
    Branch/Leaf Oil, Lavendar (Lavandula Angustifolia) Oil, Rosemary (Rosmarinus
    Officinalis) Leaf Oil, Olive (Olea Europaea) Fruit Oil, Sweet Almond (Prunus
    Amygdalus Dulcis) Oil, Peppermint (Mentha Piperita) Oil, Aloe Vera (Aloe
    Barbadensis) Leaf Juice Powder, Bitter Orange (Citrus Aurantium Amara) Flower Oil,
    Limonene, Linalool, Potassium Sorbate, Sodium Benzoate.

  • Inner Label Principal Display

    Antiac

    Multi Action
    Formula

    Acne Treatment
    Clearing Spray
    0. 5% Salicylic Acid
    Deep Cleansing Liquid
    Purifies & Soothes Skin

    8.4 fl. oz
    250ml

    Pure Natural Ingredients

    For people who
    may be prone to:
    ✓ Acne
    ✓ Whiteheads
    ✓ Blackheads
    ✓ Pimples
    ✓ Blemishes
    ✓ Oily Skin

    salcura
    NATRUAL SKIN THERAPY

    Pure & Natural
    Use on all skin types
    Contains no harmful artificial
    ingredients such as Hydrogen Peroxide
    Liquid Spray
    Quickly and easily absorbed to
    penetrate the skin deeply
    Multi-Action
    Anti-bacterial Formula
    Maximum results

    Totally free from
    Steroids Hormones Cortisones
    Peroxides Parabens Antibiotics
    Not Tested on Animals

    Salcura Natural Skin Therapy,
    Distributed Exclusively By:
    Brown Sparrow Marketing, Rochester Hills, MI 48309
    888-446-3215 | info@salcurausa.com
    www.salcurausa.com
    © Copyright 2013 Salcura is a Registered Trade Mark.

    Made in the UK.

    bottle label

  • Outer Package Principle Display

    BEST ACNE PRODUCT

    Salcura Antiac® is our most
    effective product for people prone to
    acne and blemishes anywhere on
    the body – here’s why:

    Pure & Natural
    Use on all skin types
    Contains no harmful artificial
    ingredients such as Hydrogen Peroxide
    Liquid Spray
    Quickly and easily absorbed to
    penetrate the skin deeply
    Multi-Action
    Anti-bacterial Formula
    Maximum results

    Triple Action

    Cleansing
    Gets deep into pores to expel impurities
    Cleansing
    Removes excess oil
    Soothing

    Unique Liquid Spray Action!

    Deep Absorption
    Enables the ingredients to
    cleanse as well as tackle acne
    quickly and effectively

    Easy To Use
    Gets to areas you can’t reach
    normally. No staining, no greasiness
    and no messy residue

    www.salcurausa.com

    Up to
    2000 sprays

    Who can use this product?
    • For use by adults and children over 3 years.
    • Suitable for vegans, vegetarians and those with an allergy or
    intolerance to the following: Gluten. Nuts. Soya. Dairy.
    • Suitable for use during breast-feeding or when pregnant.

    box label

  • INGREDIENTS AND APPEARANCE
    ANTIAC ACNE CLEARING 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58990-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Rosemary (UNII: IJ67X351P9)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TRIDECETH-9 (UNII: X9HD79I514)  
    Ceteareth-25 (UNII: 8FA93U5T67)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58990-000-001 in 1 BOX
    1250 mL in 1 BOTTLE, SPRAY
    2NDC:58990-000-011 in 1 BOX
    2100 mL in 1 BOTTLE, SPRAY
    3NDC:58990-000-021 in 1 BOX
    350 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/13/2013
    Labeler - Salcura Ltd (424373277)