Active Ingredient
Menthol 1.25%
Personal Care Ice Cold Gel
FDA Label NDC 76176-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Liyuan Daily Chemical Products Co., Ltd. for the product Personal Care Ice Cold (NDC 76176-021). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Topical analgesic
Uses
temporarily relieves minor muscle aches and pains of muscles and joints associated with:
arthritis, simple backache, strains, bruises, sports injuries, sprains, provides cooling penetrating relief
Warnings
For external use only.
Do not use: with other topical pain relievers, with heating pads or heating devices.
When Using This Product
do not use in or near the eyes.
do not apply to wounds or damaged skin.
do not bandage tightly.
Stop Use And Ask A Doctor If
condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness or irritation develops.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
clean affected area before applying product.
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
chidlren under 2 years of age: ask a doctor.
Other Information
store at controlled room temperature 20 to 25℃ (68 to 77°F) in a tightly closed container.
do not use, pour, spill or store near heat or open flame.
Inactive Ingredients
benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water
Package Label.Principal Display Panel
Label (90346)
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