PREMIERE'S PAIN SPRAY ROLL-ON

Manufacturer
Premiere Enterprises | Safetec of America, Inc.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:18

Label at a glance#

ProductPREMIERES PAIN
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Premiere Enterprises, Inc.

Pain Spray

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

USP Menthol 7%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles and joints.

Warnings:

WARNINGS SECTION

  • For external use only
  • Flammable.Keep away from flame.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum

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

OTC - QUESTIONS SECTION

Manufactured for:

PREMIERE ENTERPRISES, INC.

Los Angeles, CA 90034

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - Bottle Label
Principal Display Panel - Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086713menthol 7 % Topical SprayPSN6
1086713menthol 70 MG/ML Topical SpraySCD6
1086713menthol 7 % Topical SpraySY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130783239003072GTIN-13: 0783239003072
EAN-13: 0783239003072
GTIN-12: 783239003072
UPC-A: 783239003072
GTIN storage (14 digits): 00783239003072
pre08-0001-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
32472-102-03PREMIERES PAIN88 mL in 1 BOTTLESPRAY886

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3A2
mentholACTIVE MOIETYL7T10EIP3A2
coconut oilINACTIVE INGREDIENTQ9L0O73W7L2
eucalyptus oilINACTIVE INGREDIENT2R04ONI6622
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
isopropyl alcoholINACTIVE INGREDIENTND2M4163022
methyl salicylateINACTIVE INGREDIENTLAV5U5022Y2
peppermint oilINACTIVE INGREDIENTAV092KU4JH2
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
32472-10232472-102-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 74 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route
10 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
32 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route
10 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii+route
10 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
8 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii+route
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
32 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
32 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii+route
10 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii+route
10 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
32 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
32 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
4 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
8 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii+route
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+dosage form
32 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
eucalyptus oilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii+route
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
32 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
8 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
32 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREMIERES PAINMENTHOLPremiere Enterprises128bd1e7-e961-416c-933b-fbd146e3d3862025-12-23WarningsExact identifier
ndc (product): 32472-102
PREMIERES PAINMENTHOLPremiere Enterprises35ff19df-4cc4-4fce-bd30-d87d835e0e262025-12-23WarningsExact identifier
ndc (package): 32472-102-03
ndc (product): 32472-102
ndc11 (package): 32472010203
spl id: 46a6f042-1930-0688-e063-6294a90ae162
spl set id: 35ff19df-4cc4-4fce-bd30-d87d835e0e26
Premieres PainMENTHOLPremiere Enterprises1f081913-6106-4d06-a37a-631f710dbacb2025-12-23WarningsExact identifier
ndc (product): 32472-102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.