FDA.reportPublic FDA data

Extra Strength Balm

Manufacturer
Saje Natural Business Inc
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:56

Label at a glance#

ProductExtra Strength Balm
Active ingredientMENTHOL, CAPSICUM
Label structure14 sections

Storage and handling

Store in a cool, dark place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Capsicum (from Capsicum Frutescens fruit extract) 5%
Menthol 2.5%

OTC - PURPOSE SECTION

External analgesic (counterirritant)

INDICATIONS & USAGE SECTION

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 SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eyes.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use • while pregnant or breastfeeding.

OTC - DO NOT USE SECTION

Do not apply to • wounds • damaged skin • bandage tightly • with external heat. This may result in skin irritation or skin burn.

OTC - STOP USE SECTION

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 SECTION

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 SECTION

Store in a cool, dark place.

INACTIVE INGREDIENT SECTION

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 SECTION

Extra Strength Balm

Warming pain relief ointment

0.9 fl oz (25 g)

Extra Strength Balm - outer label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Balm - outer labelExtra Strength Balm - outer label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAPSICUM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-027-01Extra Strength Balm1 in 1 BOXOINTMENT14
70983-027-01Extra Strength Balm25 g in 1 JAROINTMENT254

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-02770983-027-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHEPTYL SUCCINATE057N7SS26YIACT
JOJOBA OIL724GKU717MIACT
ALMOND OIL66YXD4DKO9IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
SQUALENE7QWM220FJHIACT
TOCOPHEROLR0ZB2556P8IACT
ROSEMARYIJ67X351P9IACT
MENTHOLL7T10EIP3AACTIB
APIS MELLIFERA7S82P3R43ZIACT
OLIVE OIL6UYK2W1W1EIACT
CARDAMOM OILJM0KJ091HZIACT
COCONUT OILQ9L0O73W7LIACT
RASPBERRY SEED OIL9S8867952AIACT
CLOVE OIL578389D6D0IACT
CINNAMON LEAF OILS92U8SQ71VIACT
SOYBEAN OIL241ATL177AIACT
GINGER OILSAS9Z1SVUKIACT
CAPSICUM00UK7646FGACTIB
ROSEMARY OIL8LGU7VM393IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
ndc (package): 70983-027-01
ndc (product): 70983-027
ndc11 (package): 70983002701
spl id: 484f4f3a-5682-ca7d-e063-6394a90a982c
spl set id: f516e416-446b-8f21-e053-2a95a90afd88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.