Active Ingredients
Menthol USP 3%
Camphor USP 3%
Sore No More Gel
FDA Label NDC 61577-2280
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 Sore No More (NDC 61577-2280). 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
PurposeExternal Analgesic
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
Temporarily relieves minor aches, pains, inflammation and sor muscles associated with stiffness, arthritis, and injuries
Warnings
For external use only. Avoid contact with eyes, mucous membranes, damaged skin. Do not use with heating pads, avoid bandaging tightly.
Stop use and ask doctor if: symptoms persist
Directions
adults and children 2 years of age and older: apply to affected area liberally up to 4 times daily. Avoid contact with eyes. Wash hands after use.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Camellia Sinensis
(Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit
Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil,
Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Glycerin,
Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol,
Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca
Schidigera Root Extract
Questions Or Comments
1-800-842-6622
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Label (Glogermlabel8ozsmall)
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