Active Ingredients
Capsicum (from Capsicum Frutescens fruit extract) 5%
Menthol 2.5%
Extra Strength Balm Ointment
FDA Label NDC 69204-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natures Formulae Health Products Ltd. for the product Extra Strength Balm (NDC 69204-030). 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, uses, warnings, otc - when using, otc - pregnancy or breast feeding, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic (Counterirritant)
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.
Warnings
For external use only.
Otc - When Using
Avoid contact with the eyes
Otc - Pregnancy Or Breast Feeding
Do not use • while pregnant or breastfeeding.
Otc - Do Not Use
Do not apply to • wounds • damaged skin • bandage tightly • with external heat. This may result in skin irritation or skin burn.
Otc - Stop Use
Stop use and ask a doctor if • condition worsens, • if symptoms persist for more than 7 days • clear up and reoccur within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.
Other Information
Store in a cool, dry place.
Inactive Ingredients
Beeswax, butyrospermum parkii (shea) butter, calendula officinalis flower extract, capryloyl glycerin, cinnamomum zeylanicum (cinnamon) leaf oil, cocos nucifera (coconut) oil, diheptyl succinate, elettaria cardamomum (cardamom) seed oil, eugenia caryophyllus (clove) bud oil, glycine soja (soybean) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf oil, rubus idaeus (raspberry) seed oil, sebacic acid copolymer, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol, zingiber officinale (ginger) root oil
Package Label.Principal Display Panel
Saje
Natural Wellness
Extra Strength Balm
Warming pain relief ointment
net wt 25 g | 0.9 fl oz
* Please review the disclaimer below.
