Label: SOVEREIGN SILVER FOAMING FACIAL CLEANSER- salicylic acid/acne treatment gel gel

  • NDC Code(s): 52166-016-01
  • 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 1%

  • PURPOSE

    Acne treatment

  • INDICATIONS & USAGE

    USES for treatment of acne.Penetrates pores to eliminate most acne blemishes,blackheads and whiteheads.

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product. skin irritation and dryness is more likely to occcur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medicarion a 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 reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Take a quarter sized amount of the product in wet hands and work into a fine lather.Apply to wet face and massage for 60 seconds. Rinse with warm water and pat the skin dry. Use twice daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients Capryloyl/Caproyl Methyl Glucamide, Citric Acid, Coco-Glucoside, Cocos Nucifera(Coconut)Fruit Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Jojoba Esters, Lactobacillus,Lactobacillus Ferment, Lauroyl/Myristoyl Methyl Glucamide, Propanediol, Salix Alba(Willow) Bark Extract, Silver, Sodium Citrate, Sunfloweroyl Methylglucamide, Water, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

    Foaming Facial Cleanser Exfoliating wash

  • INGREDIENTS AND APPEARANCE
    SOVEREIGN SILVER FOAMING FACIAL CLEANSER 
    salicylic acid/acne treatment gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52166-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SILVER (UNII: 3M4G523W1G)  
    COCONUT JUICE (UNII: AMN6S4M09G)  
    LAUROYL/MYRISTOYL METHYL GLUCAMIDE (UNII: SC667B999P)  
    CAPRYLOYL/CAPROYL METHYL GLUCAMIDE (UNII: 0451R360HR)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52166-016-0159 mL in 1 BOTTLE; 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(52166-016)
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