PAIN RELIEVING- menthol, unspecified form spray 
Safetec of America, Inc.

----------

61010-1560-1, Pain Relieving Spray

Drug Facts

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

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil

Principal Display Panel - 4 oz. Bottle Label

Safetec

PAIN RELIEVING

SPRAY

FAST-ACTING MUSCLE RELIEF

with Tea Tree & Eucalyptus Oils

Reorder No. 58004

4 fl. oz. (118.3ml) • Topical Analgesic

Principal Display Panel - 4 oz. Bottle Label
PAIN RELIEVING 
menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1560
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-1560-1118.3 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/07/2019
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-1560)

Revised: 2/2024
Document Id: 10a94a5e-7097-232e-e063-6294a90a2c98
Set id: df512ce6-ce1b-434d-9571-fb2e1d76e1d0
Version: 2
Effective Time: 20240205
 
Safetec of America, Inc.