Astonea Extra Strength Anti-itch Cream

Astonea Extra Strength Anti-itch Cream
SPL v1
SPL
SPL Set ID 0d81b0dc-c86a-21bc-e063-6294a90a420a
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01
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
    • minor skin irritations
    • rashes due to poison ivy, poison oak, oak, and 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. (1-800-222-1222)

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 product

  • use only as directed
  • avoid 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 over: 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°C/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, Propylene Glycol, Sodium metabisulsulfite, Water

Astonea Extra Strength Anti Itch Cream

Structured Label Content

Uses
  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • minor skin irritations
    • rashes due to poison ivy, poison oak, oak, and 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. (1-800-222-1222)

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 product

  • use only as directed
  • avoid 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 over: 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°C/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, Propylene Glycol, Sodium metabisulsulfite, Water

Astonea Extra Strength Anti Itch Cream (ASTONEA Extra Strength Anti-Itch Cream)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.881650 · Updated: 2026-03-14T23:02:36.495120