FREDS MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream 
Discount Drug Mart

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Discount Drug Mart Medicated Anti itch Cream

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

Uses

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Purpose

Topical anagesic

Warnings

When using this product

do not get into eyes

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

store at controlled room temperature

Directions

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: consult a doctor

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

Inactive Ingredients

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

Principal Display Panel

FREDS MEDICATED ANTI ITCH 
pramoxine hydrochloride, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARETH-21 (UNII: 53J3F32P58)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
MINERAL OIL (UNII: T5L8T28FGP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-265-011 in 1 CARTON04/13/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/13/2014
Labeler - Discount Drug Mart (047741335)
Registrant - Weeks and Leo, Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo, Inc.005290028manufacture(53943-265)

Revised: 12/2023
Document Id: 0c530ae4-9788-7809-e063-6394a90a143d
Set id: 8697b932-da5a-717e-e053-2a91aa0afcae
Version: 6
Effective Time: 20231212
 
Discount Drug Mart