Ana Cool Rapid Soothing Cooling Formula Cream
FDA Label NDC 70288-714

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 Ana Cool Rapid Soothing Cooling Formula (NDC 70288-714). 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:, uses:, warnings:, do not use for, when using this product,, stop use and ask a doctor if, keep out of reach of children., directions:, 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%

Uses:

  • Temporarily relief of external anal itching
  • Temporary relief of itching associated with minor skin irritations and rashes
  • Other uses of this product should be only under the advice and supervision of a doctor

Warnings:

  • ​For external use only.​

Do Not Use 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 • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

• bleeding occurs • condition worsen • symptoms persist for more than 7 days  or clear up occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor

Keep Out Of Reach Of Children.

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

Directions:

  • Adults:​ ​​cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before the applicationof this product
  • ​Adults and children 12 years of age and older:​ apply to the affected area not more than 3 to 4 times daily.
  • ​Children under 12 years of age: ​do not use, consult a doctor

Other Information

Store at 20 - 25 °C (68-77°F)

Other Ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, cetearcth-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.

Package Labeling:

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