Otc-Active Ingredient Section
Active Ingedients Purpose
Menthol USP 3.5%................... Topical Analgesic
Elgin Pain Relief Gel
FDA Label NDC 30056-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eco-logics, Inc. for the product Elgin Pain Relief (NDC 30056-004). 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 section, warnings, otc ask doctor, when using this product:, stop use and ask a doctor if;, if pregnant or breast feeding:, keep out of reach of children., other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For External Use only.
Otc Ask Doctor
Ask a doctor before use if you have : Sensitive skin.
When Using This Product:
Avoid contact with the eyes or mucous membranes
Do not apply to wounds or damaged skin.
Do not use with other ointments, creams sprays or limiments.
Do not apply to irritated skin or if excessive irritation develops
Do not bandage
Wash hands after use with cool water
Do not use with heating pad or device
Stop Use And Ask A Doctor If;
Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.
If Pregnant Or Breast Feeding:
Ask a health professional before use.
Keep Out Of Reach Of Children.
Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison control Center immediately.
Other Information:
Store in a cool dry place with lid closed tightly.
Inactive Ingredients:
Aqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.
Dosage And Administration
Directions:
Adults and children 2 years of age and older
Apply to painful muscles and joints. Genthly massage thoroughly into affected area.
Repeat as necessary but not more than 4 times daily.
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains.
Package Label.Principal Display Panel
30056-004-04 (30056 004 04)
30056-004-03 (30056 004 03)
* Please review the disclaimer below.
