FDA.reportPublic FDA data

Pain Relieving Cream

Manufacturer
GOLDEN TIGER DISTRIBUTION L.L.C.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:35:22

Label at a glance#

ProductPain Relieving Cream
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure8 sections

Indications and uses

Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis sprains bruises strains

Dosage and administration

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician wash hands after use with cool water

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • sprains
  • bruises
  • strains

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a physician
  • wash hands after use with cool water

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)
  • store in a cool, dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Arnica Montana Flower Extract, Benzoic Acid, Boswellia Carterii Resin Extract, Camellia Sinensis Flower Extract, Capsicum Annuum Extract, Carbomer, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Methyl Sulfonyl Methane, Phenoxyethanol, Propylene Glycol, Rosa Centifolia Flower Extract, Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sorbic Acid, Vitis Vinifera (Grape) Seed Extract, Water, Zingiber Officinale (Ginger) Root Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Camphor 3% & Menthol 3%

PAIN RELIEVING CREAM

GOLDEN TIGER

with Arnica & Ginger

3 FL OZ (88.72 ML)

GT 3oz new labelGT 3oz new label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84334-000-06Pain Relieving Cream88.7 mL in 1 BOTTLE, WITH APPLICATORCREAM88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84334-000PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [GOLDEN TIGER DISTRIBUTION L.L.C.]1Current NDC, 1 package rows20241109_26473383-282c-fb10-e063-6394a90a5fa2.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84334-00084334-000-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
SALIX ALBA BARK205MXS71H7IACT
FRANKINCENSER9XLF1R1WMIACT
CAPSICUM00UK7646FGIACT
MENTHOLL7T10EIP3AACTIB
SODIUM HYDROXIDE55X04QC32IIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
SORBIC ACIDX045WJ989BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
WATER059QF0KO0RIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GINGERC5529G5JPQIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BENZOIC ACID8SKN0B0MIMIACT
ANANAS SATIVUS (PINEAPPLE) FRUIT2A88ZO081OIACT
ALOE VERA LEAFZY81Z83H0XIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.26473383-282c-fb10-e063-6394a90a5fa22024-11-06WarningsExact identifier
ndc (package): 84334-000-06
ndc (product): 84334-000
ndc11 (package): 84334000006
spl id: 26473383-282d-fb10-e063-6394a90a5fa2
spl set id: 26473383-282c-fb10-e063-6394a90a5fa2
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.1b6f929a-db65-8a02-e063-6394a90a8b592024-11-06WarningsExact identifier
ndc (product): 84334-000

Reported adverse events (FAERS/openFDA)#

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