Label: FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH- menthol cream

  • 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 March 31, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Menthol 1%.........................................................................Anti-itch/Topical analgesic

    Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

  • PURPOSE

    Uses

    • for temporary relief of pain and itching associated with:
    • minor skin irritations
    • minor cuts
    • minor burns
    • minor sunburns
    • scrapes
    • insect bites
    • rashes due to poison ivy, oak, or sumac
  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

    Do not use

    • on deep or puncture wounds
    • animals bites
    • serious burns
    • large areas of the body
  • WHEN USING

    When using this product, avoid contact with eyes or nose.

  • STOP USE

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • not for prolonged use
    • 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.
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methyl salicylate, methylparaben, mineral oil, polysorbate 60, propylparaben, purified water, sodium hydroxide, stearyl alcohol, tocopheryl acetate

  • QUESTIONS

    Questions or comments?

    Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

  • DOSAGE & ADMINISTRATION

    Distributed By: UNITED EXCHANGE CORPORATION

    Cypress, CA 90630 USA | 1-888-645-8204

    Made in China

  • PRINCIPAL DISPLAY PANEL

    10497.1

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-104-141 in 1 CARTON10/30/2018
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/24/2014
    Labeler - United Exchange Corp. (840130579)
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