Theraplex Aim Anti-itch Moisturizing Cream

Theraplex Aim Anti-itch Moisturizing Cream
SPL v1
SPL
SPL Set ID d1b231b6-cc9f-488a-9121-501831473772
Route
TOPICAL
Published
Effective Date 2024-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Petrolatum Cyclomethicone Coconut Oil Microcrystalline Wax Ferulic Acid Oatmeal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-06

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • soaps
  • detergents
  • cosmetics
  • seborrheic dermatitis
  • psoriasis.
  • Other uses of this product should only be under the advice and supervision of a doctor.
Warnings

For external use only

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, ask a doctor.
Do Not Use
  • for the treatment of diaper rash, consult a doctor.
Drug Facts

Questions?

Toll-free number 888-437-2753 For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

Active Ingredient

Hydrocortisone 1%

Other Information
  • Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Package Labeling 2oz:

Package Labeling 3oz:

When Using This Product,
  • avoid contact with eyes.
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • soaps
  • detergents
  • cosmetics
  • seborrheic dermatitis
  • psoriasis.
  • Other uses of this product should only be under the advice and supervision of a doctor.
Purpose

Anti-Itch

Warnings

For external use only

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, ask a doctor.
Do Not Use (Do not use)
  • for the treatment of diaper rash, consult a doctor.
Drug Facts

Questions?

Toll-free number 888-437-2753 For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
  • Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Package Labeling 2oz:

Package Labeling 3oz:

When Using This Product, (When using this product,)
  • avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
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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