ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate cream

itch relief by

Drug Labeling and Warnings

itch relief by is a Otc medication manufactured, distributed, or labeled by Bionpharma Inc., Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical Analgesic

Skin Protectant

Uses

■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac

■ temporarily relieves pain and itching associated with:
■ minor cuts ■ sunburn ■ scrapes
■ minor skin irritations ■ minor burns ■ insect bites

■ rashes due to poison ivy, poison oak and poison sumac

Warnings

For external use only.

Do not use

■ with any other product containing diphenhydramine, even one taken by mouth
■ on large areas of the body
■ on broken, blistered, or oozing skin

Ask a doctor before use

■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn

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
■ 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 right away.

Directions

■ children under 2 years of age: ask a doctor
■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

■ do not use more than directed

Other information

■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use
■ Lot No. & Exp. Date: See box or crimp of tube

Inactive ingredients

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60,
propylparaben, purified water, stearic acid

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

MADE IN INDIA

GUJ/DRUGS/G/25/2134

L0000814

R0424

LOT & EXP.

tube carton

* compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream

NDC: 69452-449-37

a+ health TM

itch relief cream
diphenhydramine HCl 2 % + zinc acetate 0.1%

net wt. 1.25 oz

dye-free phthalate-free fragrance-free

extra strength

topical analgesic

skin protectant

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-449
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-449-37	1 in 1 CARTON	07/16/2024
1		35.4 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 Drug	M017	07/16/2024

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	manufacture(69452-449)