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Analgesic

Premiere Enterprises
Safetec of America, Inc.

Analgesic


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

NDC 32472-102-01

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 1 fluid oz./29.5 ml.

Analgesic

menthol SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:32472-102
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 700 mL

Inactive Ingredients

Ingredient Name Strength
water
ISOPROPYL ALCOHOL
GLYCERIN
EUCALYPTUS OIL
methyl salicylate
PEPPERMINT OIL
COCONUT OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:32472-102-01 0.0295 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-03-07


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