FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH- menthol cream 
United Exchange Corp.

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.

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Family Care Anti-Itch + Pain Relief Cream 0.5oz (10497)

Active Ingredients Purpose

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

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

Uses

Warnings For external use only.

Do not use

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

Stop use and ask a doctor if

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

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

Directions

Other information

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 or comments?

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

Distributed By: UNITED EXCHANGE CORPORATION

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

Made in China

10497.1

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)

Revised: 3/2022
Document Id: db8bc5f9-c3ef-607f-e053-2995a90aa8df
Set id: 430b5753-3087-4cb1-bf54-0eedc3f4b1d5
Version: 10
Effective Time: 20220331
 
United Exchange Corp.