MEDICATED ANTI-ITCH Well At Walgreens: Package Insert and Label Information

MEDICATED ANTI-ITCH WELL AT WALGREENS- menthol and pramoxine hydrochloride 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.

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

  • Adults and children 2 years of age and older: ​ apply to the affected area no more than 4 times daily
  • Children under 2 years of age: consult a doctor

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3231
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (MENTHOL) Menthol 1 g in 100 g
Pramoxine Hydrochloride (PRAMOXINE) Pramoxine Hydrochloride 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Water
Propylene Glycol
Petrolatum
Stearyl Alcohol
ALOE VERA LEAF
Steareth-21
Mineral Oil
Steareth-2
.ALPHA.-TOCOPHEROL ACETATE
Thymol
Eucalyptol
Methyl Salicylate
PPG-1 Trideceth-6
Diazolidinyl Urea
EDETATE DISODIUM
TROLAMINE
Iodopropynyl Butylcarbamate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3231-02 1 TUBE in 1 CARTON contains a TUBE
1 56 g in 1 TUBE This package is contained within the CARTON (0363-3231-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/15/2014
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-3231), label (0363-3231)

Revised: 02/2018 Walgreens

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