Otc - Active Ingredient
Capsicum (from Capsicum Frutescens fruit extract) 5%
Menthol 2.5%
Extra Strength Balm Ointment
FDA Label NDC 70983-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc for the product Extra Strength Balm (NDC 70983-027). 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, otc - purpose, indications & usage, 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
Otc - Purpose
External analgesic (counterirritant)
Indications & Usage
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.
Dosage & Administration
Adults: 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.
Storage And Handling
Store in a cool, dark place.
Inactive Ingredient
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
Other Safety Information
Important: Read all product information before using. Keep this package for full information.
Do not use if security seal is broken or missing.
distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8
saje.com | 1-877-ask-saje | @sajewellness
made in Canada
Questions? Call 1-877-ASK-SAJE
I'm made from recycled paper
please recycle where possible
Description
Extra Strength Balm
Warming pain relief ointment
0.9 fl oz (25 g)
* Please review the disclaimer below.
