Label: AL0043600 ALBA BOTANICA VE HERBAL HEALING BODY- colloidal oatmeal lotion

  • NDC Code(s): 61995-2436-9
  • Packager: The Hain Celestial Group, Inc.
  • 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 August 16, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient

    Colloidal Oatmeal - 0.4%

  • DOSAGE & ADMINISTRATION

    Smooth over entire body after bathing and any time skin feels thirsty. Give special attention to areas under dry skin attack.

  • PURPOSE

    Skin Protectant

  • WARNINGS

    For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

  • INACTIVE INGREDIENT

    Water, Helianthus Annuus (Sunflower) Seed Oil(1), Glycerin, Glyceryl Stearate SE, Butyrospermum Parkii (Shea) Butter (1), Cetyl Alcohol, Carthamus Tinctorius (Safflower)Seed Oil (1), Cocos Nucifera (Coconut) Oil (1), Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

    (1) Certified Organicf Ingredient

  • INDICATIONS & USAGE

    Helps protect and relieve skin irritation and iching due to eczema, rashes, dry skin.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    AL0043600 ALBA BOTANICA VE HERBAL HEALING BODY 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2436
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2436-9907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/12/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.014334364manufacture(61995-2436)