WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

Weeks and Leo Extra Strength Itch Stopping by

Drug Labeling and Warnings

Weeks and Leo Extra Strength Itch Stopping by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-258
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-258-51	1 in 1 CARTON	03/17/2014
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11383-258-53	1 in 1 CARTON	03/17/2014
2		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/17/2014

Labeler - Weeks & Leo Co., Inc. (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-258)