Label: NATURAL ACNE SOLUTIONS 3 STEP REGIMEN- salicylic acid kit

  • 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 April 26, 2016

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  • Active Ingredients

    SALICYLIC ACID 1.0%

  • Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    PENETRATES PORES TO CONTROL ACNE.

    HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES

  • WARNINGS

    FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION 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.

    Keep out of reach of children IF SWALLOWED, GET MEDICATL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    APPLY TO FACE IN THE MORNING AND EVENING AFTER CLEANSING. IF BOTHERSOME DRYNESS OCCURS, REDUCE TO ONCE A DAY OR EVERY OTHER DAY.

  • INACTIVE INGREDIENTS

    WATER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, STEARIC ACID, SUCROSE POLYSTEARATE, SALIX NIGRA (WILLOW) BARK EXTRACT, BEESWAX, CYMBOPOGON SCHOENANTHUS EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, HUMULUS LUPULUS (HOPS) EXTRACT, EQUISETUM HIEMALE EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, EPILOBIUM FLEISCHERI EXTRACT, LECITHIN, CHONDRUS CRISPUS (CARAGEENAN), FRAGRANCE, GLUCOSE, XANTHAN GUM, SUCROSE, SUCROSE STEARATE, POTASSIUM SORBATE, SODIUM CHLORIDE, GLUCOSE OXIDASE, LACTOPEROXIDASE, PHENOXYETHANOL.

  • QUESTIONS?

    800-849-7112 OR WWW.BURTSBEES.COM

  • ACTIVE INGREDIENTS

    SALICYLIC ACID 1.0%

  • PURPOSE

    ACNE TREATMENT

  • USES

    PENETRATES PORES TO CONTROL ACNE.

    HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES.

  • WARNINGS

    FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION 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 WHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

    Keep out of reach of children. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    WASH FACE IN THE MORNING AND EVENING AVOIDING THE EYE AREA. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

  • QUESTIONS?

    800-849-7112 OR WWW.BURTSBEES.COM

  • INACTIVE INGREDIENTS

    WATER, DECYL GLUCOSIDE, LAURYL GLUCOSIDE, SUCROSE LAURATE, SALIX NIGRA (WILLOW) BARK EXTRACT, COCO-BETAINE, BETAINE, BETA VULGARIS (BEET) ROOT EXTRACT, CENOTHERA BIENNIS (EVENING PRIMROSE) LEAF EXTRACT, SODIUM COCOYL HYDROLYZED SOY PROTEIN, HYDROXYPROPYLTRIMONIUM HONEY, GLYCERIN, GLYCERYL OLEATE, COCO GLUCOSIDE, FRAGRANCE, GLUCOSE, ALCOHOL DENAT., GLUCOSE OXIDASE, LACTOPEROXIDASE, CITRIC ACID, SODIUM CHLORIDE, PHENOXYETHANOL.

  • ACTIVE INGREDIENT

    Salicylic Acid 0.75%

  • PURPOSE

    Acne Treatment

  • Uses

    • Penetrates pores to control acne
  • Warnings

    For external use only. Using other topical acne medication at the same time or immediately following use of this product may increased dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

  • Directions

    Apply to face in the morning and evening after cleansing.

  • Inactive Ingredients

    Inactive Ingredients: alcohol denat., citrus medica limonum (lemon) peel oil, water, achillea millefolium extract, borago officinalis extract, calendula officinalis flower extract, carum petroselinum (parsley) extract, foeniculum vulgare (fennel) oil, salix nigra (willow) bark extract, melaleuca alternifolia (tea tree) leaf oil, eucalyptus globulus leaf oil, juniperus communis fruit oil

  • QUESTIONS

    Questions? 800-849-7112 or www.burtsbees.com

  • PRINCIPAL DISPLAY PANEL

    BURTS BEES

    Natural

    ACNE SOLUTIONS

    1 Purifying Gel Cleanser

    2 Daily Moisturizing Lotion

    3 Targeted Spot Treatment

    3 Step Regimen Kit Salicylic Acid Acne Treatment from Willow Bark

    Acne Regimen Kit

  • INGREDIENTS AND APPEARANCE
    NATURAL ACNE SOLUTIONS 3 STEP REGIMEN 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-035
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-035-101 in 1 BOX; Type 0: Not a Combination Product01/02/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, PLASTIC 1 mL  in 100 
    Part 20 BOTTLE, WITH APPLICATOR 1 g  in 100 
    Part 30 BOTTLE, PUMP 1 g  in 100 
    Part 1 of 3
    NAS PURIFYING CLEANSER 
    salicylic acid gel
    Product Information
    Item Code (Source)NDC:26052-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SUCROSE LAURATE (UNII: 05Q7CD0E49)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYLTRIMONIUM CHLORIDE FRAGMENT (UNII: N30M4819DB)  
    BETA VULGARIS (UNII: 4G174V5051)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    BETAINE (UNII: 3SCV180C9W)  
    OENOTHERA BIENNIS LEAF (UNII: 153YBS895W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-010-02145 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/01/2010
    Part 2 of 3
    NAS TARGETED SPOT TREATMENT 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:26052-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    LEMON OIL (UNII: I9GRO824LL)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    PARSLEY OIL (UNII: IXK9N7RJ7J)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    FENNEL OIL (UNII: 59AAO5F6HT)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-011-037.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/01/2010
    Part 3 of 3
    NAS DAILY MOISTURIZING 
    salicylic acid lotion
    Product Information
    Item Code (Source)NDC:26052-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    LEVOGLUCOSE (UNII: 02833ISA66)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    EPILOBIUM FLEISCHERI WHOLE (UNII: 8E2KLS8J8K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    EQUISETUM HYEMALE (UNII: 59677RXH25)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    SUCROSE (UNII: C151H8M554)  
    LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-012-0155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/02/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/02/2014
    Labeler - Burt's Bees (613480946)
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