Label: HYR FACIAL AND BODY ACNE- 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 October 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic Acid, 2%

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses

    for the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Sunburn Alert:This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun. Avoid unnecessary sun exposure and use a sunscreen of SPF 15 or higher.

    When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the skin thoroughly before applying this product
    • spray the entire affected area with a thin layer one to three times daily
    • 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 INGREDIENT

    Inactive ingredientswater, glycolic acid, ethyl alcohol, ammonium hydroxide, hamamelis virginiana (witch hazel) water, acetone, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA, benzoic acid

  • SPL UNCLASSIFIED SECTION

    Distributed by: General Resources • 227 S Smith Rd Suite 102 • Tempe, AZ 85281 • www.gen-resources.com

  • PRINCIPAL DISPLAY PANEL

    HYR

    FACIAL & BODY

    ACNE SPRAY

    Salicylic Acid Acne Treatment

    Net 2 fl. oz. (60 ml)

    Proudly made in the USA

    Acne-FacialBody-Salicylic-v3

  • INGREDIENTS AND APPEARANCE
    HYR FACIAL AND BODY ACNE 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70481-331
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AMMONIA (UNII: 5138Q19F1X)  
    ACETONE (UNII: 1364PS73AF)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    IMIDUREA (UNII: M629807ATL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70481-331-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    2NDC:70481-331-12120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/19/2020
    Labeler - General Resources LLC (117648210)
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