QC MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream 
Chain Drug Marketing Association

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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QC 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

Dosage

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

Package principal panel

Carton

QC MEDICATED ANTI ITCH 
pramoxine hydrochloride, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-959
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
TROLAMINE (UNII: 9O3K93S3TK)  
PETROLATUM (UNII: 4T6H12BN9U)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARETH-21 (UNII: 53J3F32P58)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-959-011 in 1 CARTON12/07/2020
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 not finalpart34812/07/2020
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
WEEKS & LEO COMPANY, INC.005290028manufacture(63868-959)

Revised: 12/2020
Document Id: b5e41e3a-81e0-3a63-e053-2a95a90a5839
Set id: b5e41e3a-81df-3a63-e053-2a95a90a5839
Version: 1
Effective Time: 20201207
 
Chain Drug Marketing Association