Your browser does not support JavaScript! ANALGESIC (MENTHOL) SPRAY [PREMIERE ENTERPRISES]
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ANALGESIC (menthol) spray
[Premiere Enterprises]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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.

PRINCIPAL DISPLAY PANEL
ANALGESIC 
menthol spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:32472-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (menthol) menthol700 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water 
isopropyl alcohol 
glycerin 
eucalyptus oil 
methyl salicylate 
peppermint oil 
coconut oil 
xanthan gum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:32472-102-030.088 L in 1 BOTTLE
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

Revised: 1/2011
 
Premiere Enterprises

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