Active Ingredients
Menthol 1%
Insect Bite Relief Spray
FDA Label NDC 82953-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Insect Bite Relief (NDC 82953-026). 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, otc - when using, otc - stop use, otc - 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
Purpose
Anti-itch
Insect bite relief spray
Uses
Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.
Warnings
For external use only.
Do Not Use
- in or near the eyes
- for disper rash; ask a doctor
Otc - When Using
Ask a doctor before use if you are using any other hydrocortisone product.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or if symptoms persist for more than 7 days
- symptoms last more than 7 days or clear up and occur again within a few days
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.
Directions
- Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years, do not use; ask a doctor.
Other Information
Protect from excessive heat (40 oC/ 104 oF)
Inactive Ingredients
Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol.
Indications & Usage
Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.
* Please review the disclaimer below.
