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Analgesic

Premiere Enterprises
Safetec of America, Inc.

PREMIERE'S PAIN SPRAY ROLL-ON


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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:

  • 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, Xanthan Gum

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

Manufactured for:

PREMIERE ENTERPRISES, INC.

Los Angeles, CA 90034

PRINCIPAL DISPLAY PANEL

NDC 32472-102-03

PREMIERE'S

Pain Spray™

Roll-On

A miracle in every bottle!

TEMPORARY RELIEF OF

MINOR ACHES & PAINS

ARTHRITIS ● BACKACHE

STIFF JOINTS ● SORE MUSCLES

SPRAINS ● BRUISES

NATURAL MENTHOL ● HERBAL FORMULA

Net 3 fluid oz./88 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
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:32472-102-03 0.088 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-01-12


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