Extra Strength Balm

Extra Strength Balm
SPL v1
SPL
SPL Set ID 498a5e2a-4de0-561c-e063-6394a90ac05c
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsicum (5 g) Menthol (2.5 g)
Inactive Ingredients
Elettaria Cardamomum Seed Oil Simmondsia Chinensis (jojoba) Seed Oil Rosmarinus Officinalis (rosemary) Leaf Oil Squalane Zingiber Officinale (ginger) Root Oil Rubus Idaeus (raspberry) Seed Oil Cocos Nucifera (coconut) Oil Olea Europaea (olive) Fruit Oil Tocopherol Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Eugenia Caryophyllus (clove) Bud Oil Rosemary Hydrogenated Castor Oil/sebacic Acid Copolymer Theobroma Cacao (cocoa) Seed Butter Cinnamomum Zeylanicum Leaf Oil Calendula Officinalis Flower Beeswax Brassica Campestris (rapeseed) Seed Oil Prunus Amygdalus Dulcis (sweet Almond) Oil Diheptyl Succinate Butyrospermum Parkii (shea) Butter Soybean Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

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

Purpose

Topical Analgesic (Counterirritant)


Medication Information

Purpose

Topical Analgesic (Counterirritant)

Description

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

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.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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.

Section 50567-7

Avoid contact with the eyes

Section 50570-1

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

Section 51945-4

Saje

Natural Wellness

Extra Strength Balm

Warming pain relief ointment

net wt 25 g | 0.9 fl oz

Section 53414-9

Do not use • while pregnant or breastfeeding.

Warnings

For external use only.

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.

Active Ingredients

Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

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


Structured Label Content

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.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

Avoid contact with the eyes

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Saje

Natural Wellness

Extra Strength Balm

Warming pain relief ointment

net wt 25 g | 0.9 fl oz

Section 53414-9 (53414-9)

Do not use • while pregnant or breastfeeding.

Purpose

Topical Analgesic (Counterirritant)

Warnings

For external use only.

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.

Active Ingredients

Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

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


Advanced Ingredient Data


Raw Label Data

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