Label: CONTROLLING BALM WITH TEA TREE OIL- salicylic acid emulsion

  • NDC Code(s): 35192-018-07
  • Packager: CA-BOTANA INTERNATIONAL
  • 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 January 8, 2021

If you are a consumer or patient please visit this version.

  • WARNINGS

    Warnings:

    For external use only.
    Do not use on wounds or damaged skin
    When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
    Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
    Store at room temperature. Lot number and expiration date see crimp or see box.

  • DOSAGE & ADMINISTRATION

    cleanse the skin thoroughly with soft foam deep cleanse before applying. cover the entire affected aread with a thin layer 1 to 2 times daily. because too much drying of the skin may occure, start with 1 application daily, then gradually increase to 2 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

    Acrilates/Acrylamine Copolymer
    Aloe barbadensis (Aloe vera) extract
    Alpha Copper Tripeptide-4 TM
    Argania Spinosa (Argan) extract
    Benzyl Alcohol
    Camellia sinensis (White tea) extract
    Chamomilla recutita (Chamomile) extract
    Cinnamomum Zeylanicum
    Citrus medica lemonum (Lemon)Peel Oil
    Copper Gluconate
    Ethanol
    Ethylhexylglycerin
    Euterpe oleracea (Acai) extract
    Gingko Biloba extract
    Glycine
    Hamamelis virginiana (Witchhazel) extract
    Hypericum perforatum (St John's wort) extract
    Juniperus communis (Juniper) extract
    Lactic acid
    Lavandula angustifolia oil
    Malpighia glabra (Acerola) extract
    Melaleuca Alternifolia (Tea tree) leaf oil
    Olea europaea (Olive) leaf extract
    Phenoxyethanol
    Phosphatidylcholine
    Pinus Taeda (Pine tree) extract
    Polysorbate 20
    Potassium Sorbate
    Propanediol
    Punica granatum (Pomegranate) extract
    Rosa canina extract
    Rosmarinus officinalis (Rosemary) extract
    Sodium Hyaluronate
    Sodium Hydroxide
    Sodium PC
    Tetra sodium
    Vitis Vinifera ( Grape) extract
    Water (Aqua)
    Xanthan Gum
  • ACTIVE INGREDIENT


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

  • INDICATIONS & USAGE

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  • PURPOSE

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

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  • Package Label display panel

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  • INGREDIENTS AND APPEARANCE
    CONTROLLING BALM WITH TEA TREE OIL 
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.89 mg  in 237 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COPPER (UNII: 789U1901C5)  
    ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
    .ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOL (UNII: JE030BGE05)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CINNAMON (UNII: 5S29HWU6QB)  
    LEMON OIL (UNII: I9GRO824LL)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACAI (UNII: 46AM2VJ0AW)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCINE (UNII: TE7660XO1C)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PINUS TAEDA BARK (UNII: 9I1F994SVG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
    ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    VITIS VINIFERA FLOWERING TOP (UNII: 6TG3V35HTV)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: H026DM5V6U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-018-07237 mg in 1 BOTTLE; Type 0: Not a Combination Product11/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/09/2014
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-018)