WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream 
Weeks & Leo Co., Inc.

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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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:

dries the oozing and weeping due to poison:

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

Other Information

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)

pdp

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-258-511 in 1 CARTON03/17/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11383-258-531 in 1 CARTON03/17/2014
256 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 finalpart34803/17/2014
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(11383-258)

Revised: 3/2017
Document Id: 4b2a349b-93cf-5ef5-e054-00144ff8d46c
Set id: 4b2a349b-93ce-5ef5-e054-00144ff8d46c
Version: 3
Effective Time: 20170320
 
Weeks & Leo Co., Inc.