Skin A Cool Hydrocortisone Anti-itch Cream
FDA Label NDC 70288-173

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ana-cool, Llc for the product Skin A Cool Hydrocortisone Anti-itch (NDC 70288-173). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose, uses:, warnings:, do not use for, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Hydrocortisone 1.0%

Purpose

Anti-itch

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.

Do Not Use For

  • for the treatment of diaper rash. Consult a doctor.

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.

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.

Adults: 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").:

Children under 12 years of age: consult a doctor.

Other Information:

Store at 20-25°C (68-77°F)

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.

Questions?

visit: skin-a-cool.com

Package Labeling:

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