Label: LAVADERM AFTER SUN FOR PAIN AND ITCHING- menthol spray

  • NDC Code(s): 70631-034-25
  • Packager: Young Living Essential Oils, LC
  • 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 January 9, 2023

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  • Active ingredient

    Menthol 0.5%

  • Purpose

    Topical analgesic

  • Uses

    • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Shake Well

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor

  • Other information

    • store at controlled room temperature (68° to 77°F)
  • Inactive ingredients

    Water, olive oil, glycerin, safflower oil, sunflower oil, jojoba oil, polyglyceryl-10 pentastearate, glyceryl monocaprylate, helianthus annuus seed wax, European elderberry, xanthan gum, docosanol, sodium stearoyl lactylate, lavender oil, aloe vera leaf, glyceryl monoundecylenate, phytate sodium, picea mariana leaf oil, helichrysum italicum flower oil, citric add

  • Questions or comments?

    call 1-800-371-3515

  • Principal Display Panel

    FOR PAIN & ITCH

    SOOTHES & COOLS SKIN

    IMMEDIATE RELIEF

    Box

    Label

  • INGREDIENTS AND APPEARANCE
    LAVADERM AFTER SUN  FOR PAIN AND ITCHING
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70631-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    WATER (UNII: 059QF0KO0R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70631-034-251 in 1 BOX04/05/2017
    157 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/05/2017
    Labeler - Young Living Essential Oils, LC (836136630)
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