Active Ingredients
Menthol USP 6%
Herbal Freeze
FDA Label NDC 61577-3385
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Herbal Freeze (NDC 61577-3385). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
External Analgesic
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches, strains, bruises, and sprains
Warnings
For external use only. Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, consult a healthcare professional before use.When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.
Directions
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed,
children under 2 years of age: consult a doctor.
Inactive Ingredients
Purified Water, Ethyl Alcohol, Arnica Montana (Arnica) Flower Extract, Populus Balsimafora (Balsam Poplar) Bud Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Glycerin
Questions Or Comments
1-877-239-4667
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Label (Herbalfreeze)
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