Label: SOVEREIGN SILVER ACNE SPOT TREATMENT MEDICATED SERUM- salicylic acid liquid

  • NDC Code(s): 52166-017-01
  • Packager: Natural Immunogenics Corporation
  • 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 September 21, 2023

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  • ACTIVE INGREDIENT

    Salicylic Acid 2%

  • PURPOSE

    Acne treatment

  • INDICATIONS & USAGE

    Uses for treatment of acne. Clears acne blemishes ans allows skin to heal. Helps prevent acne blemishes.

  • WARNINGS

    For external use only.

  • WHEN USING

    When usin 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 medicarion at a time.

  • STOP USE

    Stop use and ask a doctor if. skin irritation occurs or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions After cleansing, cover the affected area with a thin layer of product. Start with one application a day and then gradually increase to two or three applications daily if needed,or as directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients Arginine, Cocos Nucifera(Coconut) Fruit Extract,Glycerin,Hydrolized Sodium Hyaluronate,Lactobacillus, Lactobacillus Ferment, Niacinamide,Panthenol, Propanediol, Sodium Citrate, Silver, Water, Xanthan Gum, Zinc PCA

  • PRINCIPAL DISPLAY PANEL

    Acne Spot treatment medicated serum

  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVER ACNE SPOT TREATMENT MEDICATED SERUM 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52166-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 29 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC (UNII: J41CSQ7QDS)  
    COCONUT JUICE (UNII: AMN6S4M09G)  
    SILVER (UNII: 3M4G523W1G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ARGININE (UNII: 94ZLA3W45F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52166-017-0129 mL in 1 TUBE; Type 0: Not a Combination Product07/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/24/2023
    Labeler - Natural Immunogenics Corporation (048744085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions081030372manufacture(52166-017)
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