EXTRA STRENGTH- menthol and methyl salicylate oil

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Saje Natural Business Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
External analgesic (Counterirritant) For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains 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 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.
Authorization status:
OTC monograph not final
Authorization number:
70983-023-01

EXTRA STRENGTH- menthol and methyl salicylate oil

Saje Natural Business Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Extra Strength

Menthol 10.5%, Methyl Salicylate 13.4%

External analgesic (Counterirritant)

For the temporary relief of minor aches and pains of muscles and joints associated with: simple back

ache arthritis strains bruise sprains

For external use only

Flammable

Keep away from fire and flame

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

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

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.

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

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

Centre right way.

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

Store at room temperature.

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

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

Extra Strength

Pain Relieving Oil Blend

1.5 fl oz (45 ml)

Extra Strength

EXTRA STRENGTH

menthol and methyl salicylate oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 9 8 3-0 23

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Saje Natural Business Inc.

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

9 4.41 mg in 1 mL

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

123.74 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CHAMAEMELUM NO BILE (UNII: 7NF3GE7IWR)

KUNZEA AMBIGUA WHO LE (UNII: R0 9 L248 6 DI)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

O RIGANUM MAJO RANA (UNII: R40 XM3HU5X)

RO SEMARY O IL (UNII: 8 LGU7VM39 3)

TRIFO LIUM PRATENSE FLO WER (UNII: 4JS0 8 38 8 28 )

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

BETULA LENTA BARK (UNII: J6 8 9 T0 DVJQ)

ELETTARIA CARDAMO MUM WHO LE (UNII: KH2S76 26 7N)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 9 8 3-

0 23-0 1

1 in 1 BOX

0 5/13/20 19

1

45 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a

Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/13/20 19

Labeler -

Saje Natural Business Inc. (203413380)

Revised: 5/2019

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