Label: INSECT BITE RELIEF 01- menthol spray

  • NDC Code(s): 82953-011-01, 82953-011-02, 82953-011-03
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • 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 July 14, 2023

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  • Drug Facts

  • Active Ingredients

    Menthol 1%

  • Purpose

    Anti-itch

    Insect bite relief spray

  • Uses

    Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

  • Warnings

    For external use only.

  • Do not use

    • in or near the eyes
    • for disper rash; ask a doctor
  • WHEN USING

    Ask a doctor before use if you are using any other hydrocortisone product.

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days
    • 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years, do not use; ask a doctor.
  • Other information

    Protect from excessive heat (40 oC/ 104 oF)

  • Inactive ingredients

    Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol, Glycerin

  • INDICATIONS & USAGE

    Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.

  • PRINCIPAL DISPLAY PANEL

    82953-011

  • INGREDIENTS AND APPEARANCE
    INSECT BITE RELIEF  01
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    BORNEOL (UNII: M89NIB437X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-011-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
    2NDC:82953-011-0220 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
    3NDC:82953-011-0110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/30/2022
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-011)
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