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Name:Analgesic
Manufacturer:Premiere Enterprises
Category:Over-the-counter (OTC) Marketed Drugs


PREMIERE'S PAIN SPRAY

ANALGESIC - 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

Premiere Enterprises, Inc.

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. 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.

Questions or Comments?

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

Manufactured for:
PREMIERE ENTERPRISES, INC.
Los Angeles, CA 90034

PRINCIPAL DISPLAY PANEL

NDC 32472-102-04

PREMIERE'S

Pain Spray™

A miracle in every bottle!

TEMPORARY RELIEF OF

MINOR ACHES & PAINS

ASSOCIATED WITH

  • ARTHRITIS
  • BACKACHE
  • STIFF JOINTS
  • SORE MUSCLES
  • SPRAINS
  • BRUISES

NATURAL MENTHOL

HERBAL FORMULA

PAIN RELIEVING SPRAY

Net 4 fluid oz./118 ml.

PRINCIPAL DISPLAY PANEL

ANALGESIC 
menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:32472-102
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
menthol (menthol) menthol 700 mL  in 1 L
Inactive Ingredients
Ingredient Name Strength
water  
isopropyl alcohol  
glycerin  
eucalyptus oil  
methyl salicylate  
peppermint oil  
coconut oil  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:32472-102-04 0.118 L in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/28/2010

Labeler - Premiere Enterprises (556225498)
Registrant - Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE

Revised: 01/2011 Premiere Enterprises



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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