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NDC 32472-0102-01 PREMIERES PAIN 0.07 g/mL Details

PREMIERES PAIN 0.07 g/mL

PREMIERES PAIN is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Premiere Enterprises. The primary component is MENTHOL.

Product Information

NDC	32472-0102
Product ID	32472-102_bbc86983-10f7-496c-bf71-304e51eac2df
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PREMIERES PAIN
Proprietary Name Suffix	n/a
Non-Proprietary Name	menthol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	0.07
Active Ingredient Units	g/mL
Substance Name	MENTHOL
Labeler Name	Premiere Enterprises
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 32472-0102-01 (32472010201)

Pricing Information	N/A
NDC Package Code	32472-102-01
Billing NDC	32472010201
Package	29.5 mL in 1 BOTTLE (32472-102-01)
Marketing Start Date	2011-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 128bd1e7-e961-416c-933b-fbd146e3d386 Details

SPL UNCLASSIFIED SECTION

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

NEW LOOK

SAME FORMULA

ARTHRITIS

BACKACHE

STIFF JOINTS

SORE MUSCLES

SPRAINS

MUSCLE CRAMPS

Net 4 fluid oz./118 ml.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	.07 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:32472-102-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2010

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

Labeler - Premiere Enterprises (556225498)

Registrant - Safetec of America, Inc. (874965262)

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

Revised: 6/2015

Document Id: bbc86983-10f7-496c-bf71-304e51eac2df

Set id: 128bd1e7-e961-416c-933b-fbd146e3d386

Version: 4

Effective Time: 20150617