THERACARE 2% DIPHENHYDRAMINE ANTI-ITCH CREAM- diphenhydramine hydrochloride and zinc acetate cream

TheraCare 2% Diphenhydramine Anti-Itch Cream by

Drug Labeling and Warnings

TheraCare 2% Diphenhydramine Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Umendra Life Sciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Diphenhydramine hydrochloride 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

Uses

• temporarily relieves pain and itching 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

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 productavoid contact with 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

• adults and children 2 years of age and overr: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician

Other information

• store at 20˚C-25 ˚C (68˚F-77˚F)
• do not use if tube seal under cap is broken

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, polyethylene glycol, sodium metabisulfite, water

Questions or comments?

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Manufacturer for:

Veridian Healthcare, LLC

PRINCIPAL DISPLAY PANEL 

INGREDIENTS AND APPEARANCE

THERACARE 2% DIPHENHYDRAMINE ANTI-ITCH CREAM 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-014
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 ACETATE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLOROCRESOL (UNII: 36W53O7109)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-014-01	1 in 1 CARTON	10/01/2025
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	10/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Umendra Life Sciences		878533295	manufacture(71101-014)