Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only.

Flammable.

Keep away from flame.

Keep out of reach of children.

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes.

Do not apply to open wounds or damaged skin. Do not bandage tightly.

Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates,including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Principal Display Panel - Pain Relief Spray Bottle Label

NDC 61010-XXXX-X

Safetec

PAIN
RELIEF
SPRAY

MEDICATED FAST-ACTING

For temporary relief of minor aches and pains

2 fl. oz. (59.1 ml)

Principal Display Panel - Pain Relief Spray Bottle Label

ANALGESIC
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-8201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	70 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCONUT OIL (UNII: Q9L0O73W7L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61010-8201-0	0.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/01/2018

Labeler - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc		874965262	manufacture(61010-8201)

61010-8201. Pain Relief Spray