Label: LUCKY SUPERSOFT MEDICATED BODY TRIPLE ACTION- menthol zinc oxide powder

  • NDC Code(s): 20276-980-08, 20276-980-14
  • Packager: Delta Brands Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 27, 2022

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  • 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

  • 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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    GUM TALHA (UNII: H18F76G097)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    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
    2NDC:20276-980-14397 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2022
    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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