Viaderma Calm Anti-itch Ointment

Viaderma Calm Anti-itch Ointment
SPL v1
SPL
SPL Set ID 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Acetic Acid Ascorbic Acid Butylated Hydroxyanisole Butylated Hydroxytoluene Cholecalciferol Dimethyl Sulfoxide Dipropylene Glycol Gluconolactone Glycerin Histidine Hydroxyethyl Cellulose, Unspecified Magnesium Stearate Sodium Hydroxide Sorbic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-17

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema • detergents

• insect bites • cosmetics

• poison ivy • jewelry

• poison oak • seborrheic dermatitis

• poison sumac • psoriasis

• soaps

Purposes

Anti-Itch

Warnings

For external use only.

Avoid contact with the eyes

Drug Facts

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Do Not Use
  • it for the treatment of diaper rash
  • Consult a doctor
Questions?

Report any serious adverse events

to: Viaderma Distribution Inc. or call:

1-800-585-8685.

Email: www.viadermainc.com

Other Ingredients

Acetic acid, ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, gluconolactone, glycerin, histidine, hydroxyethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, water.

Package Labeling:

Active Ingredients

Hydrocortisone 1%

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema • detergents

• insect bites • cosmetics

• poison ivy • jewelry

• poison oak • seborrheic dermatitis

• poison sumac • psoriasis

• soaps

Purposes

Anti-Itch

Warnings

For external use only.

Avoid contact with the eyes

Drug Facts (DRUG FACTS)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Do Not Use (Do not use)
  • it for the treatment of diaper rash
  • Consult a doctor
Questions?

Report any serious adverse events

to: Viaderma Distribution Inc. or call:

1-800-585-8685.

Email: www.viadermainc.com

Other Ingredients (Other ingredients)

Acetic acid, ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, gluconolactone, glycerin, histidine, hydroxyethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, water.

Package Labeling:

Active Ingredients (Active ingredients)

Hydrocortisone 1%

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.


Advanced Ingredient Data


Raw Label Data

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