EXTRA STRENGTH BALM- capsicum and menthol ointment

Extra Strength Balm by

Drug Labeling and Warnings

Extra Strength Balm by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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.

WHEN USING

Avoid contact with the eyes.

PREGNANCY OR BREAST FEEDING

Do not use while pregnant or breastfeeding.

DO NOT USE

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

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)

KEEP OUT OF REACH OF CHILDREN

Extra Strength Balm - outer label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH BALM 
capsicum and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2258.75 mg  in 1 g
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	5000 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
JOJOBA OIL (UNII: 724GKU717M)
ALMOND OIL (UNII: 66YXD4DKO9)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SQUALENE (UNII: 7QWM220FJH)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
APIS MELLIFERA (UNII: 7S82P3R43Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
CARDAMOM OIL (UNII: JM0KJ091HZ)
COCONUT OIL (UNII: Q9L0O73W7L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CLOVE OIL (UNII: 578389D6D0)
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
SOYBEAN OIL (UNII: 241ATL177A)
GINGER OIL (UNII: SAS9Z1SVUK)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-027-01	1 in 1 BOX	02/24/2023
1		25 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/18/2023

Labeler - Saje Natural Business Inc (080465432)