WALGREENS ANTI ITCH: Package Insert and Label Information

WALGREENS ANTI ITCH — diphenhydramine hydrochloride and zinc acetate cream
WALGREEN COMPANY

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

Diphenhydramine Hydrochloride 1%…………………………………………….Topical analgesic

Zinc acetate 0.1%…………………………………………………………………..Skin protectant

Uses

temporarily relieves pain and itching associated with

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak, and poison sumac
Dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

  • Store between 20o C and 25o C (68o F and 77o F)

Inactive ingredients

cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Made in Korea

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WALGREENS ANTI ITCH
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1411
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 1 g in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1411-01 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (0363-1411-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 03/01/2012
Labeler — WALGREEN COMPANY (008965063)

Revised: 03/2012 WALGREEN COMPANY

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