FDA.reportPublic FDA data

Pain Relieving Cream

Manufacturer
GOLDEN TIGER DISTRIBUTION L.L.C.
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:11

Label at a glance#

ProductPain Relieving Cream
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 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: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 3%

Purpose

OTC - PURPOSE SECTION

Pain Reliever

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 - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

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 immediately.

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: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20° to 25° C (68° to 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Decyl Glucoside, Phenoxyethanol, Benzoic Acid, Sorbic Acid, Aloe Barbadensis Leaf [Aloe Vera], Capsicum Frutescens Resin, Hamamelis Virginiana [Witch Hazel] Leaf Extract, Camellia Sinensis Leaf Extract [Green Tea], Methylsulfonylmethans [MSM], Boswellia Serrata Extract, Zingiber Officinale [Ginger] Root Extract, Bromelain [Pineapple Extract], Arnica Montana Flower Extract, Salix Nigra [Willow] Bark Extract, Rosa Centifolia Flower Water [Rose Water], Vitis Vinifera [Grape] Seed Extract

SPL UNCLASSIFIED SECTION

Questions? Or to reorder, call 505-857-9500 or 866-817-9500

www.goldentigerusa.com

Made in USA

Mfr. for Golden Tiger, Albuq, NM

No Animal Testing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOLDEN TIGER

NATURAL PAIN RELIEVING CREAM

Enriched with Capsaicin, Aloe Vera,

Willow Bark & MSM

NET WT 4 oz (113.39 mg)

Old GT 4oz tubeOld GT 4oz tube

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84334-001-002025-07-29C16284748780-13b156c62-3025-fb37-e063-e6dba90a4e071d13a4ac-b35b-3b55-e063-6394a90aa08a
84334-001-022025-07-29C16284748780-13b156c62-3025-fb37-e063-e6dba90a4e071d13a4ac-b35b-3b55-e063-6394a90aa08a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84334-001-00Pain Relieving Cream5 mg in 1 PACKETCREAM51
84334-001-02Pain Relieving Cream113.39 mg in 1 TUBECREAM113.391

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84334-001PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [GOLDEN TIGER DISTRIBUTION L.L.C.]12 package rows20240713_1d13a4ac-b35b-3b55-e063-6394a90aa08a.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84334-00184334-001-00, 84334-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPSICUM OLEORESINUW86K581WYIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BENZOIC ACID8SKN0B0MIMIACT
GLYCERINPDC6A3C0OXIACT
ROSA CENTIFOLIA FLOWER OILH32V31VMWYIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GINGERC5529G5JPQIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
GREEN TEA LEAFW2ZU1RY8B0IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBIC ACIDX045WJ989BIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
BROMELAINSU182GP2CF3IACT
SALIX NIGRA BARKQU52J3A5B3IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
1d13a4ac-b35c-3b55-e063-6394a90aa08a1d13a4ac-b35b-3b55-e063-6394a90aa08a2024-07-12WarningsExact identifier
spl id: 1d13a4ac-b35c-3b55-e063-6394a90aa08a
spl set id: 1d13a4ac-b35b-3b55-e063-6394a90aa08a

Reported adverse events (FAERS/openFDA)#

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