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Weeks and Leo Extra Strength Itch Stopping

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 20mg in 1g, ZINC ACETATE 1mg in 1g
Labeler: Weeks & Leo Co., Inc.
NDC Code: 11383-258

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.

Extra Strength Itch Stopping Cream Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Uses

temporarliy relieves pain and itching due to:

  • 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 due to poison:

  • ivy
  • oak
  • 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

do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last 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 right away

Directions
  • do not use more often than directed
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

Other Information
  • store at 20º C to 25º C (68º F to 77º F)

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

Package Label - 1oz (28g)

Extra Strength

Est. 1892 WEEKS&LEO Professional Health

ITCH STOPPING CREAM

Topical Analgesic / Skin Protectant

Net wt. 1 oz (28 g)

WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING 
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-258
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (ZINC CATION) ZINC CATION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
WATER 
PROPYLPARABEN 
PROPYLENE GLYCOL 
PEG-40 STEARATE 
PEG-100 STEARATE 
CETYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:11383-258-511 TUBE in 1 CARTON
128 g in 1 TUBE
2NDC:11383-258-531 TUBE in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/17/2014
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIOperations
Weeks & Leo Co., Inc.005290028manufacture(11383-258)

Revised: 03/2017
 
Weeks & Leo Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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