FDA.reportPublic FDA data

PAINGEL

Manufacturer
NACOR BUSINESS GROUP LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:29

Label at a glance#

ProductPAINGEL
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure14 sections

Dosage and administration

Adults and children over 12 years of age apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily. Wash hands with soap and water after use. Children under 12 years of age. Do not use unless directed by a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor ………………. 6%

Menthol …………….…. 10%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS SECTION

  • For external use only.
  • Use only as directed.
  • Do not bandage tightly.
  • Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have redness over affected area.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes, mucous membranes, rashes.
  • Do not apply to wounds or damaged skin.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

If pregnant of breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age

  • apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.
  • Wash hands with soap and water after use.

Children under 12 years of age. Do not use unless directed by a doctor.

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15° - 30°C (59° - 86°F)

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Polysorbate 60, Polyacrylamide, Propylene Glycol, Tocopheryl Acetate, Stearyl Alcohol, Polysorbate 20, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

Contact us +1-307-533-7345

PAINGEL TOPICAL CREAM TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PG tubePG tube

PAINGEL TOPICAL CREAM SACHET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PG SACHETPG SACHET

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2727767camphor 6 % / menthol 10 % Topical CreamPSN1
2727767camphor 60 MG/ML / menthol 100 MG/ML Topical CreamSCD1
2727767camphor 6 % / menthol 10 % Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130755439009703GTIN-13: 0755439009703
EAN-13: 0755439009703
GTIN-12: 755439009703
UPC-A: 755439009703
GTIN storage (14 digits): 00755439009703		FD-04730 PAINGEL PAIN RELIEF CREAM SACHET.jpg
BarcodeEAN-130755439009734GTIN-13: 0755439009734
EAN-13: 0755439009734
GTIN-12: 755439009734
UPC-A: 755439009734
GTIN storage (14 digits): 00755439009734		FD-04730 PAINGEL PAIN RELIEF CREAM TUBE.jpg
QR code linkQR Codepaingelnbg.com/FD-04730 PAINGEL PAIN RELIEF CREAM TUBE.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85110-610-04PAINGEL113 g in 1 TUBECREAM1131
85110-610-33PAINGEL9 g in 1 PACKETCREAM91

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85110-61085110-610-04, 85110-610-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
XANTHAN GUMTTV12P4NEEIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYSORBATE 207T1F30V5YHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
LAURETH-7Z95S6G8201IACT
TRIETHANOLAMINE9O3K93S3TKIACT
CETEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
MENTHOLL7T10EIP3AACTIB
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE230OU9XXE4IACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
PARAFFINUM LIQUIDUMT5L8T28FGPIACT
ALCOHOL3K9958V90MIACT
POLYSORBATE 60CAL22UVI4MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
ndc (package): 85110-610-04
ndc (package): 85110-610-33
ndc (product): 85110-610
ndc11 (package): 85110061033
ndc11 (package): 85110061004
spl id: 42f94460-c3a6-b32a-e063-6294a90aadb5
spl set id: 42fa2397-b61a-3b16-e063-6294a90a5fed

Reported adverse events (FAERS/openFDA)#

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