Cooling Itch Relief
FDA Label NDC 0363-3106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Cooling Itch Relief (NDC 0363-3106). 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 ingredient                                purpose, uses, warnings, flammable: do not use while smoking or near heat or flame, do not use, when using this product, stop use and ask a doctor if, keep out of reach of the children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

Uses

Temporarily relieves itching associated with minorskin irritation and rashes due to:

• eczema           • poison ivy, oak and sumac         • cosmetics

• psoriasis         • soaps and detergents                  • jewelry

• insect bites     • seborrheic dermatitis

Warnings

For external use only

Flammable: Do Not Use While Smoking Or Near Heat Or Flame

Do Not Use

• in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

When Using This Product

• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure
• Do not store at temperature above 120F

Stop Use And Ask A Doctor If

• condition worsens or does not improve withing 7 days
• symptomspersist more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of The Children

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

Directions

• shake well
• 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

• to apply to face, spray into palm of hand and gently apply

Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

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