Label: ACNE RELIEF CREAM- salicylic acid 0.5% cream

  • 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 March 17, 2021

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  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Salicylic Acid 0.5%..Acne Treatment

  • Uses

    For the treatment of acne.

  • Warnings

    For external use only

    When using this product

    • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

  • Directions

    • cleanse the skin thoroughly before applying the medication
    • cover 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 of peeling occurs, reduce application to once a day or every other day
  • Other information

    • Store in a cool dry place away from light
  • Inactive ingredients

    water (aqua), coco-caprylate, organic dog rose (rosa canina) fruit oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, citric acid, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, zinc oxide (Cl 77947), sorbitan olivate, caprylic/capric triglyceride, willow (salix nigra) bark extract, oat (avena sativa) kernel flour, organic aloe (aloe barbadensis) leaf juice, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, cetearyl glucoside, glucose, polyhydroxystearic acid, lysolecithin, pullulan, xanthan gum, sclerotium gum, isostearic acid, linalool, limonene, silica, lactoperoxidase, glucose oxidase, organic cypress (cupressus sempervirens) oil, organic lavender (lavandula angustifolia) oil, peppermint (mentha piperita) oil

  • QUESTIONS

    Manufactured for HempFusion(r)

    3820 NW 14th Street Suite A & B

    Topeka, ks 66618

    877.NOW.HEMP (877.669.4367)

    hempfusion.com

  • PRINCIPAL DISPLAY PANEL

    HempFusion

    Acne

    Relief

    CREAM

    Salicylic Acid 0.5%

    Including nourishing Willow Bark, hemp extract with naturally occuring CBD (60mg/bottle) + Terpenes (35mg/bottle) from black pepper and clove & other natural skin moisturizers

    US HEMP AUTHORITY H CERTIFIED

    NON-GMO

    ALL SKIN TYPES

    30mL (1.01 fl oz)

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    ACNE RELIEF CREAM 
    salicylic acid 0.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-981
    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
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    CLOVE OIL (UNII: 578389D6D0)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE (UNII: V5VD430YW9)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HEMP (UNII: TD1MUT01Q7)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    WILLOW BARK (UNII: S883J9JDYX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-981-301 in 1 CARTON02/10/2020
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/10/2020
    Labeler - HEMPFUSION, INC. (117152485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab)177711082manufacture(73672-981)
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