FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP.]

FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-104-14
Set ID 430b5753-3087-4cb1-bf54-0eedc3f4b1d5
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART346
  • 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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