Otc Active Ingredient Section
Hydrocortisone 1% Anti itch
Principal Display Panel Anti Itch Spray.jpg
Cooling Itch Relief Spray
FDA Label NDC 13709-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals, Inc for the product Cooling Itch Relief (NDC 13709-310). 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 section, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of the children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Inactive Ingredient
Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water
Dosage And Administration
See Attached Image File Principal Display Panel Anti Itch Spray
Indication & Usage
For the temporary relief of itching associated with minor
skin irritation and rashes due to: • eczema • poison ivy, oak and
sumac • cosmetics • jewelry • soaps and detergents • insect
bites. Other uses of this product should be only under the advice
and supervision of a doctor.
Warnings
For external use only.
Flammable: Keep away from fire or flame
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children
If swallowed, get medical help or contact a Poison Control Center right away
* Please review the disclaimer below.
