MEDICATED ANTI-ITCH WELL AT WALGREENS- menthol 1 % pramoxine hydrochloride 1 % cream 
Walgreens

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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Drug Facts

Active ingredients                                     Purpose

Menthol – 1.00%                                        Pain Reliever   
Pramoxine Hydrochloride – 1.00%            External Analgesic

​Uses​ For temporarily relief of pain and itching associated with:• sunburn • minor burns • scrapes • insect bites • minor skin irritation • minor cuts • rashes due to poison ivy, oak & sumac

Warnings
For external use only

​Do not use on​ • deep or puncture wounds • animal bites • serious burns • large areas of the body

When using this product • Avoid contact with eyes • not for prolonged use

Stop use and ask a doctor if

• condition worsens
• symptoms persisit more than 7 days or clear up and occur again within a few days

Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Store at room temperature.

Inactive ingredients

Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
Iodopropynyl Butylcarbamate

Questions or comments?
1-866-483-2846

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MEDICATED ANTI-ITCH  WELL AT WALGREENS
menthol 1 % pramoxine hydrochloride 1 % cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3231
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)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Petrolatum (UNII: 4T6H12BN9U)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Steareth-21 (UNII: 53J3F32P58)  
Mineral Oil (UNII: T5L8T28FGP)  
Steareth-2 (UNII: V56DFE46J5)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Thymol (UNII: 3J50XA376E)  
Eucalyptol (UNII: RV6J6604TK)  
Methyl Salicylate (UNII: LAV5U5022Y)  
PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3231-021 in 1 CARTON09/15/2014
156 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 finalpart34809/15/2014
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-3231) , label(0363-3231)

Revised: 2/2018
Document Id: b917119c-dd16-4bdc-ae23-4f6e8efe5275
Set id: 32275ee3-7afd-4272-a47b-bb26bc045f72
Version: 2
Effective Time: 20180215
 
Walgreens