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FDA Approval

Tiger Balm

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Haw Par Healthcare Ltd.
DUNS: 659207039
Effective Date
October 3, 2024
Labeling Type
HUMAN OTC DRUG LABEL
Synthetic camphor(80 mg in 1 1)
menthol, unspecified form(24 mg in 1 1)

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Tiger Balm (Malaysia) Sdn. Bhd.

Haw Par Healthcare Ltd.

813058014

Haw Par Healthcare Ltd.

Haw Par Healthcare Ltd.

659207039

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tiger Balm Pain Relieving Cool

Product Details

NDC Product Code
66761-325
Application Number
M017
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
October 3, 2024
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
UREAInactive
Code: 8W8T17847WClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
Code: 5TJD82A1ETClass: ACTIBQuantity: 80 mg in 1 1
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6Class: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662Class: IACT
KAOLINInactive
Code: 24H4NWX5COClass: IACT
MENTHA ARVENSIS LEAF OILInactive
Code: 1AEY1M553NClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
CASTOR OILInactive
Code: D5340Y2I9GClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
menthol, unspecified formActive
Code: L7T10EIP3AClass: ACTIBQuantity: 24 mg in 1 1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
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