CVS EXTRA STRENGTH ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate ointment

CVS Extra Strength Itch Relief by

Drug Labeling and Warnings

CVS Extra Strength Itch Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Diphenhydramine hydrochloride 2%...................Topical Analgesic
Zinc acetate....................................................Skin protectant

PURPOSE

Uses

- for the temporary relief of itching and pain 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
 
 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.

INDICATIONS & USAGE

Uses

- for the temporary relief of itching and pain 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

Warnings

For external use only

Do not use on large areas of the body or with any other product containing diphenhydramine,
even one taken by mouth

Ask a doctor before use on chicken pox or on measles

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days,
or symptoms persist for ore 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.

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor

children under 2 years of age: consult a doctor

Other information

- store at 20 degrees - 25 degrees C (68 to 70 degrees F) - Lot No. and Exp. Date, see crimp of tube or see box
 

INACTIVE INGREDIENT

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate,
propylene glycol, propylparaben, purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EXTRA STRENGTH ITCH RELIEF 
diphenhydramine hydrochloride and zinc acetate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-053
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 - UNII:J41CSQ7QDS)	ZINC ACETATE	12 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-2 (UNII: V56DFE46J5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-100 (UNII: 4OH5W9UM87)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-053-03	1 in 1 CARTON
1		28 g in 1 TUBE
2	NDC: 59779-053-11	1 in 1 CARTON
2		14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/13/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture