Cvs Cools Itch Fast Gel
FDA Label NDC 59779-729

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Cools Itch Fast (NDC 59779-729). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                             Purpose

Hydrocortisone 1%......................... Anti-itch

Otc - Purpose

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

  • eczema
  • insect bites
  • poison ivy
  • posion oak
  • poison sumac
  • soaps
  • jewlery
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dematitis
  • temporarily relievs external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

Otc - When Using

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if

  • symptoms last more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Otc - 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.

Indications & Usage

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissure or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Storage And Handling

contents filled by weight, not volume

Inactive Ingredient

Inactive ingredients

aloe vera leaf, carbomer homopolymer type c, glycerin, methylparaben, oat kernel oil, propylene glycol, propylparaben, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax

Dosage & Administration

DISTRIBUTED BY:

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

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