Skin A Cool Hydrocortisone Anti-itch Cream

Skin A Cool Hydrocortisone Anti-itch Cream
SPL v2
SPL
SPL Set ID e3ea7406-e494-4038-9b28-8d0a28b4b834
Route
TOPICAL
Published
Effective Date 2021-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Water Alkyl (c12-15) Benzoate Green Tea Leaf Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Monostearate Hamamelis Virginiana Top Sunflower Oil Peg-100 Stearate Petrolatum Phenoxyethanol Stearyl Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Hydrocortisone 1.0%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1.0%

Uses:
  • Temporary relief of skin itching.
  • The temporary relief of itching associated with minor skin irritations and rashes.
  • Other uses of this product should be only under the advise and supervision of a doctor.
Warnings:

For external use only.

Questions?

visit: skin-a-cool.com

Directions:

Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:

Do not use, consult a doctor. Children under 2 years of age:

When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults:

consult a doctor. Children under 12 years of age:

Do Not Use For
  • for the treatment of diaper rash. Consult a doctor.
Package Labeling:

Other Information:

Store at 20-25°C (68-77°F)

Active Ingredients:

Hydrocortisone 1.0%

Inactive Ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

When Using This Product
  • Avoid contact with the eyes.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly. 
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted 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:
  • Temporary relief of skin itching.
  • The temporary relief of itching associated with minor skin irritations and rashes.
  • Other uses of this product should be only under the advise and supervision of a doctor.
Purpose

Anti-itch

Warnings:

For external use only.

Questions?

visit: skin-a-cool.com

Directions:

Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:

Do not use, consult a doctor. Children under 2 years of age:

When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults:

consult a doctor. Children under 12 years of age:

Do Not Use For (Do not use for)
  • for the treatment of diaper rash. Consult a doctor.
Package Labeling:

Other Information:

Store at 20-25°C (68-77°F)

Active Ingredients:

Hydrocortisone 1.0%

Inactive Ingredients: (Inactive ingredients:)

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

When Using This Product (When using this product)
  • Avoid contact with the eyes.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly. 
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted 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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