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Analgesic by Safetec of America, Inc.

Dosage form: spray
Ingredients: menthol 700mL in 1L
Labeler: Safetec of America, Inc.
NDC Code: 61010-8200

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.

Safetec of America, Inc. 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:
  • For external use only
  • Flammable. Keep away from flame.

  • 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)

ANALGESIC 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (menthol) menthol700 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water 
isopropyl alcohol 
glycerin 
eucalyptus oil 
methyl salicylate 
peppermint oil 
coconut oil 
Packaging
#Item CodePackage Description
1NDC:61010-8200-10.118 L in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/26/2011
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

 
Safetec of America, Inc.

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Medically reviewed on Oct 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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