Otc - Active Ingredient
Menthol 16%
Kroger Cool And Heat Roll-on Liquid
FDA Label NDC 30142-585
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Kroger Cool And Heat Roll-on (NDC 30142-585). 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, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Indications & Usage
For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.
Warnings
For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 2 years or older: clean affected area before applying product, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
Inactive Ingredient
Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum.
Package Label.Principal Display Panel
Carton (Kro Chrlr 25 R1)
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