Extra Strength

Extra Strength
SPL v8
SPL
SPL Set ID 87d872b3-3231-d0f2-e053-2995a90a9d98
Route
TOPICAL
Published
Effective Date 2022-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (94.41 mg) Salicylic Acid (123.74 mg)
Inactive Ingredients
Chamaemelum Nobile Kunzea Ambigua Whole Lavender Oil Origanum Majorana Rosemary Oil Trifolium Pratense Flower Grape Seed Oil Peppermint Betula Lenta Bark Elettaria Cardamomum Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-13

Description

Menthol 10.5%, Methyl Salicylate 13.4%


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 back ache • arthritis • strains • bruise • sprains

Dosage and Administration

Adults: apply to affected area no more than 3 to 4 times daily.

Description

Extra Strength

Pain Relieving Oil Blend

0.68 fl oz (20 ml)

Extra Strength

Pain Relieving Oil Blend

1.5 fl oz (45 ml)

Section 44425-7

Store at room temperature.

Section 50565-1

Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.

Section 50566-9

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil

Section 50570-1

Do not use on wounds or damaged skin

Do not bandage tightly

Do not use if you are allergic to plants of the asteraceae/compositae/daisy family

Section 51727-6

Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, rosmarinus officinalis (rosemary) leaf oil, syzygium aromaticum bud oil, vitis vinifera (grape) seed oil

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

External analgesic (Counterirritant)

Section 55106-9

Menthol 10.5%, Methyl Salicylate 13.4%

Section 60561-8

Important: Read all product information before using. Keep this package for full information.

Do not use if security seal around bottle is broken or missing.

Questions? Call 1-877-275-7253



distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness

Flammable

Keep away from fire and flame

Extra Strength 20 Ml and 45 Ml


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains

Dosage and Administration (34068-7)

Adults: apply to affected area no more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

For external use only

Description (34089-3)

Extra Strength

Pain Relieving Oil Blend

0.68 fl oz (20 ml)

Extra Strength

Pain Relieving Oil Blend

1.5 fl oz (45 ml)

Section 44425-7 (44425-7)

Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil

Section 50570-1 (50570-1)

Do not use on wounds or damaged skin

Do not bandage tightly

Do not use if you are allergic to plants of the asteraceae/compositae/daisy family

Section 51727-6 (51727-6)

Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, rosmarinus officinalis (rosemary) leaf oil, syzygium aromaticum bud oil, vitis vinifera (grape) seed oil

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

External analgesic (Counterirritant)

Section 55106-9 (55106-9)

Menthol 10.5%, Methyl Salicylate 13.4%

Section 60561-8 (60561-8)

Important: Read all product information before using. Keep this package for full information.

Do not use if security seal around bottle is broken or missing.

Questions? Call 1-877-275-7253



distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness

Flammable

Keep away from fire and flame

Extra Strength 20 Ml and 45 Ml (Extra Strength 20 ml and 45 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)