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Premieres Pain

Dosage form: spray
Ingredients: menthol 7g in 100mL
Labeler: Premiere Enterprises
NDC Code: 32472-102

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.

Analgesic

PREMIERE'S PAIN SPRAY
Premiere Enterprises, Inc.

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses:

Temporary relief of minor aches & 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. Get extra relief by using after warm shower or bath. 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 for: PREMIERE ENTERPRISES, Los Angeles, CA 90034
800-576-7616 / www.Amazing-Solutions.com

Principal Display Panel - Bottle Label

NDC# 32472-102-01

PREMIER'S

PAIN SPRAY

A Miracle in Every Bottle!

Temporary Relief
of Minor Aches
& Pains

• ARTHRITIS • SORE MUSCLES

• BACKACHE • SPRAINS

• STIFF JOINTS • MUSCLE CRAMPS

Net 1 fluid oz./29.5 ml.

NATURAL MENTHOL • HERBAL FORMULA

PREMIERES PAIN 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:32472-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (menthol) menthol7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
isopropyl alcohol 
glycerin 
eucalyptus oil 
methyl salicylate 
peppermint oil 
coconut oil 
Packaging
#Item CodePackage Description
1NDC:32472-102-0129.5 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/07/2011
Labeler - Premiere Enterprises (556225498)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(32472-102)

Revised: 10/2015
 
Premiere Enterprises

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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