Theracare 2% Diphenhydramine Anti-itch Cream

Theracare 2% Diphenhydramine Anti-itch Cream
SPL v1
SPL
SPL Set ID 5999b677-63dd-49c6-b5b8-7b3c117ecc5c
Route
TOPICAL
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg) Zinc Cation (1 mg)
Inactive Ingredients
Light Mineral Oil Ceteth-20 Cetostearyl Alcohol Propylene Glycol Petrolatum Water Sodium Metabisulfite Edetate Disodium Chlorocresol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01
Description

Drug Facts

Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50567-7

When using this productavoid contact with eyes

Section 50569-3

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant

Warnings

For external use only.

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?

ca ll 1-866-326-1313

Principal Display Panel 

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this productavoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1 (50570-1)

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1 (55105-1)
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant

Warnings

For external use only.

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

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

Questions Or Comments? (Questions or comments?)

ca ll 1-866-326-1313

Principal Display Panel  (PRINCIPAL DISPLAY PANEL )

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:38.450233 · Updated: 2026-03-14T23:12:56.390264