PREMIERES PAIN- menthol spray

Premiere Pain Roll On by

Drug Labeling and Warnings

Premiere Pain Roll On by is a Otc medication manufactured, distributed, or labeled by Premiere Enterprises, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 - 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

INGREDIENTS AND APPEARANCE

PREMIERES PAIN 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 32472-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 32472-102-03	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/12/2011

Labeler - Premiere Enterprises (556225498)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(32472-102)