PREMIERES PAIN- menthol spray 
Premiere Enterprises

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.

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PREMIERE'S PAIN SPRAY ROLL-ON

Premiere Enterprises, Inc.

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses:

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. 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, Xanthan Gum

1-800-576-7616 Amazing-Solutions.com

Manufactured for:

PREMIERE ENTERPRISES, INC.

Los Angeles, CA 90034

Principal Display Panel - Bottle Label

NDC# 32472-102-03

PREMIERE'S
PAIN SPRAY
ROLL ON

A Miracle in Every Bottle¡

Temporary Relief
Of Minor Aches
& Pains

MINOR SPORTS INJURIES

BACKACHES SORE MUSCLES

SPRAINS ARTHRITIS

MUSCLE CRAMPS

Net 3 fluid oz./88ml.

Natural Menthol • Herbal Formula

Principal Display Panel - Bottle Label
PREMIERES PAIN 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:32472-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol7 g  in 100 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)  
xanthan gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:32472-102-0388 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/12/2011
Labeler - Premiere Enterprises (556225498)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(32472-102)

Revised: 1/2011
Document Id: 8452dfb4-72d3-4f3c-85db-21e24acf45b0
Set id: 35ff19df-4cc4-4fce-bd30-d87d835e0e26
Version: 4
Effective Time: 20110112
 
Premiere Enterprises