Otc - Active Ingredient Section
Menthol 1.5% Camphor 3.1%
Lusti Therapeutic Ice Analgesic Rub
FDA Label NDC 49681-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New Life Products, Inc. for the product Lusti Therapeutic Ice Analgesic Rub (NDC 49681-010). 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, otc - purpose section, warnings section, otc - do not use section, otc - ask doctor section, otc - when using section, otc - stop use section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose Section
Topical Analgesic. Temporarily relieves the minor aches and paiins associated with simple backache, arthritis, sprains, strains and bruises.
Warnings Section
For external use only
Otc - Do Not Use Section
Do not use on wounds or damaged skin. Do not use with a heating pad. Do not use on a child under 12 years of age with arthritis-like conditions.
Otc - Ask Doctor Section
Ask a doctor before use if you have redness over the affected area.
Otc - When Using Section
Avoid contact with eyes or mucous membranes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use Section
Stop use of this product and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again or excessive skin irritation occurs.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions Section
Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat three to four times daily.
Inactive Ingredient Section
Inactive ingredients: Water (Aqua), Propylene Glycol, Mineral Oil, Carbomer, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Blue 1
Otc - Questions Section
Questions or comments: www.jflabs.comJF LABS, INC. Chicago, Illinois 60629
Package Label.
BONUS SIZE
Lusti
PROFESSIONAL
Therapeutic ICE
Analgesic Rub
NET WT. 10 OZ. e 284g
Deep Penetrating
Greaseless Pain Relief
Fast relief from minor
arthritis, backache, muscle,
and joint pain
* Please review the disclaimer below.
