Extra Strength Balm

Extra Strength Balm
SPL v4
SPL
SPL Set ID f516e416-446b-8f21-e053-2a95a90afd88
Route
TOPICAL
Published
Effective Date 2023-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2258.75 mg) Capsicum (5000 mg)
Inactive Ingredients
Diheptyl Succinate Jojoba Oil Almond Oil Calendula Officinalis Flower Shea Butter Cocoa Butter Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Squalene Tocopherol Rosemary Apis Mellifera Olive Oil Cardamom Oil Coconut Oil Raspberry Seed Oil Clove Oil Cinnamon Leaf Oil Soybean Oil Ginger Oil Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-18

Description

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


Medication Information

Warnings and Precautions

For external use only.

Indications and 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.

Dosage and 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.

Description

Extra Strength Balm

Warming pain relief ointment

0.9 fl oz (25 g)

Section 44425-7

Store in a cool, dark place.

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 51727-6

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

Section 53414-9

Do not use • while pregnant or breastfeeding.

Section 55105-1

External analgesic (counterirritant)

Section 55106-9



Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

Section 60561-8

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

Extra Strength Balm Outer Label


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Description (34089-3)

Extra Strength Balm

Warming pain relief ointment

0.9 fl oz (25 g)

Section 44425-7 (44425-7)

Store in a cool, dark place.

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 51727-6 (51727-6)

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

Section 53414-9 (53414-9)

Do not use • while pregnant or breastfeeding.

Section 55105-1 (55105-1)

External analgesic (counterirritant)

Section 55106-9 (55106-9)



Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

Section 60561-8 (60561-8)

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

Extra Strength Balm Outer Label (Extra Strength Balm - outer label)


Advanced Ingredient Data


Raw Label Data

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