ANALGESIC- menthol spray 
Safetec of America, Inc.

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61010-8200, PAIN SPRAY

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

Warnings:

  • Keep out of reach of children-if swallowed get medical help or contact a poison 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.

Manufactured by
SAFETEC OF AMERICA, Inc. Buffalo, NY 14215
800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

PRINCIPAL DISPLAY PANEL

ANALGESIC 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-8200-1118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/26/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/26/2011
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-8200)

Revised: 3/2024
Document Id: 12b7defb-8710-5fd7-e063-6294a90a8a03
Set id: b0f4010c-995f-40e1-aa40-92760e697a61
Version: 2
Effective Time: 20240302
 
Safetec of America, Inc.