Active Ingredient(S)
H2O 66.19%
GLYCERIN 23%
2-BORNEOL 0.2%
Menthol 0.01%
Cooling Patch
FDA Label NDC 84776-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Qiyirenkang Biotechnology Co., Ltd. for the product Cooling Patch (NDC 84776-001). 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(s), purpose, use, warnings, do not use, otc - when using, otc - 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
Purpose
Antipyretic
Use
For localized cooling of patients with fever. Only for body surface intact skin.
Warnings
1. Do not stick to the eyes and mouth.
2. Do not use if you have eczema, redness, trauma or allergy.
3. External patches, do not ingest, children should be used under the supervision of parents.
4. The product is a one-time use product, not reusable.
Do Not Use
Children should use it under parental supervision
Otc - When Using
Tear off the bag, remove the protective membrane of the patch, stick it on the forehead and other clean places, and for speeding up the speed of cooling, you can use several additional patches
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
Tear off the bag, remove the protective membrane of the patch, stick it on the forehead and other clean places, and for speeding up the speed of cooling, you can use several additional patches
Inactive Ingredients
SODIUM POLYACRYLAT
CARBOXYMETHYLCELLULOSE SODIUM CMC
DMDM HYDANTOIN
POLYETHYLENE GLYCOL 400
EDETATE DISODIUM
TARTARIC ACID
20% POVIDONE K90
1%FD&C BLUE NO. 1
Package Label - Principal Display Panel
Undefined (Label)
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