Otc - Active Ingredient
DRUG FACTS
Active ingredients Purpose
Menthol (1%)................................Topical Analgesic
Personal Care Ice Cold
FDA Label NDC 29500-2278
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Inc. for the product Personal Care Ice Cold (NDC 29500-2278). 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, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, indications & usage, 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
Otc - Purpose
Uses-For the temporary relief of minor aches and pains in muscles and joints associated with:
simple backache
sports injuries
strains
arthritis
sprains
bruises
Warnings
warnings
For external use only
Otc - Do Not Use
Do not use with other topical pain relievers
with heating pads or heating devices
Otc - When Using
When using this product
do not use in or near eyes
do not apply to wounds or damaged skin
do not bandage tightly
Otc - Stop Use
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
Indications & Usage
For the temporary relief of aches and pains in muscles and joints associated with
simple backache
sports injuries
strains
arthritis
sprains
bruises
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.
Dosage & Administration
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.
Inactive Ingredient
Inactive Ingredients: carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water(aqua), FDandC blue no 1
Package Label.Principal Display Panel
DISTRIBUTED BY PERSONAL CARE PRODUCTS INC
Bingham Farms MI 48025-2463 USA
Made in China
Personal Care Ice Cold Analgesic Gel
Net wt. 8oz (227g)
Gellabelpdp (Analgesicgel Label1pdp)
* Please review the disclaimer below.
