EXTRA STRENGTH- menthol and methyl salicylate oil

Extra Strength by

Drug Labeling and Warnings

Extra Strength 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

Menthol 10.5%, Methyl Salicylate 13.4%

PURPOSE

External analgesic (Counterirritant)

INDICATIONS & USAGE

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

WARNINGS

For external use only

Flammable

Keep away from fire and flame

DO NOT USE

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

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Store at room temperature.

INACTIVE INGREDIENT

Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, trifolium pratense (clover) flower extract, vitis vinifera (grape) seed oil

OTHER SAFETY INFORMATION

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

DESCRIPTION

Extra Strength
Pain Relieving Oil Blend
1.5 fl oz (45 ml)

Extra Strength

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH 
menthol and methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	94.41 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	123.74 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
KUNZEA AMBIGUA WHOLE (UNII: R09L2486DI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
ROSEMARY OIL (UNII: 8LGU7VM393)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PEPPERMINT OIL (UNII: AV092KU4JH)
BETULA LENTA BARK (UNII: J689T0DVJQ)
ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-023-01	1 in 1 BOX	05/13/2019
1		45 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/13/2019

Labeler - Saje Natural Business Inc. (203413380)