Active Ingredient
Menthol 5%
Camphor 3%
Healthy Back Institute Rub On Relief Cream
FDA Label NDC 79804-618
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eagle Labs Inc. for the product Healthy Back Institute Rub On Relief (NDC 79804-618). 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 ingredient, purpose, uses:, warnings:, keep out of reach of children, if pregnant or breast-feeding:, stop usage immediately and as a doctor if:, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
For Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:
For external use only ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage
Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops
Keep Out Of Reach Of Children
Keep out of the reach of children.
If accidentally swallowed get medical help or contact a Poison Control Center immediately.
If Pregnant Or Breast-Feeding:
If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately
Stop Usage Immediately And As A Doctor If:
The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops
When Using This Product
When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight
Other Information
Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)
Directions:
Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.
Inactive Ingredients:
Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.
Rub The Pain Away
Rub On Relief Net Wt 3.0 OZ (88mL)
* Please review the disclaimer below.
