TRAUMA LESS- menthol ointment

Trauma Less by

Drug Labeling and Warnings

Trauma Less by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc., Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

DRUG FACTS Active ingredient

Menthol 1.27%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Do not use

• on wounds or damaged skin
• if allergic to plants of the asteraceae/compositae/daisy family.

When using this product

• avoid contact with the eyes
• do not bandage tightly

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 breast-feeding,

ask a doctor before use.

Keep out of reach of children. 

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Apply to affected area 

DOSAGE & ADMINISTRATION

      not more than 3 times daily.

• Not recommended for children under 12 years of age.

Inactive ingredients

Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil.

Questions?

1-877-275-7253

SPL UNCLASSIFIED SECTION

Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

DO NOT USE IF SECURITY SEAL AROUND TIN IS BROKEN OR MISSING.

SKU 435301

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DISPOSAL AND WASTE HANDLING

We support recycling.  Please recycle where possible. 

Trauma Less Topical Analgesic Ointment

Saje® Natural Wellness

Trauma Less

Topical Analgesic Ointment

net wt. 1.91 oz | 54.1 g and net wt. 0.47 oz | 13.5 g

INGREDIENTS AND APPEARANCE

TRAUMA LESS 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-009-01	1 in 1 BOX	10/16/2016
1		54.1 g in 1 CANISTER; Type 0: Not a Combination Product
2	NDC: 70983-009-02	13.5 g in 1 CANISTER; Type 0: Not a Combination Product	10/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Labeler - Saje Natural Business Inc. (203413380)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(70983-009)