LUCKY SUPERSOFT MEDICATED BODY TRIPLE ACTION (MENTHOL ZINC OXIDE) POWDER [DELTA BRANDS INC]

LUCKY SUPERSOFT MEDICATED BODY TRIPLE ACTION (MENTHOL ZINC OXIDE) POWDER [DELTA BRANDS INC]
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NDC 20276-980-08
Set ID 603c6f66-93e1-0484-e053-2a91aa0a075a
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    Menthol 0.15%
    Zinc oxide 1.0%

  • Purpose

    Anti-itch

    Skin protectant

  • Uses

    temporarily relieves the pain and itch associated with:

    ■ minor cuts ■ sunburn ■ insect bites ■ scrapes ■ minor burns ■ minor skin irritations

  • Warnings

    For external use only

  • Do not use on

    ■ broken skin ■ deep or puncture wounds ■ serious burns

  • When using this product

    ■ avoid contct with eyes ■ ​keep away from face and mouth to avoid breathing powder

  • Stop use and ask a doctor if

    ■ if condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness, irritation, swelling or pain persists or increases

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    ■ for aduts and children 2 years and older: apply freely up to 3 or 4 times daily ■ for children under 2 years: ask a doctor ■ for best results dry skin thoroughly before applying​

  • Other information

    ■ this product is sold by weight, not by volume ■ settling will occur during handling & shipping

  • Inactive ingredients

    acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalcium phsphate, zea mays (corn) starch, zinc stearate

  • Package Label

    PAckage Label

    Directions

    Apply as needed, dry skin completely prior to using. Children under 2 years of age, consult a doctor.

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT MEDICATED BODY  TRIPLE ACTION
    menthol zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-980
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GUM TALHA (UNII: H18F76G097)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-980-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/11/2017
    Labeler - Delta Brands Inc (102672008)

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