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NDC 66403-0308-25 Tiger Balm Red 110; 100 mg/g; mg/g Details

Tiger Balm Red 110; 100 mg/g; mg/g

Tiger Balm Red is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Tiger Balm (Malaysia) Sdn. Bhd.. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	66403-0308
Product ID	66403-308_6a2ab4cb-4105-4739-8c54-21a226ac8577
Associated GPIs
GCN Sequence Number	006068
GCN Sequence Number Description	menthol/camphor OINT. (G) TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	80890
HICL Sequence Number	002600
HICL Sequence Number Description	MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Tiger Balm Red
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Camphor (Synthetic) and Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	110; 100
Active Ingredient Units	mg/g; mg/g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Labeler Name	Tiger Balm (Malaysia) Sdn. Bhd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66403-0308-25 (66403030825)

Pricing Information	N/A
NDC Package Code	66403-308-25
Billing NDC	66403030825
Package	1 JAR in 1 BOX (66403-308-25) / 18 g in 1 JAR
Marketing Start Date	2002-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e2e3d225-1503-4391-9c35-1ef707e6264c Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Camphor 11%	Topical Analgesic
Menthol 10%	Topical Analgesic

Uses

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

Warnings

For external use only

When using this product

Use only as directed
Avoid contact with eyes and mucous membranes
Do not apply to wounds, damaged or irritated skin
Do not bandage or cover with wrap or use heating pad
Do not use 1 hour prior to bathing or 30 minutes after bathing.

Stop use and ask a doctor if

Condition worsens
Severe skin irritation occurs
Pain persists for more than 7 days
Pain clears up and then recurs a few days later.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

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

Directions

For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily

For children 12 years of age or younger, consult a doctor before use.

Other Information

This product may cause allergic reaction in some individuals. Test on small area before use
Tiger Balm Red Extra Strength may stain cloth items. To avoid possibility of stains, use Tiger Balm White Regular Strength or Tiger Balm Ultra Strength.

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholised Mint Oil and Paraffin Petrolatum.

Questions/Comments

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 18 g Carton

NDC 66403-308-35

TIGER BALM®

RED EXTRA STRENGTH

"WORKS WHERE IT HURTS"

PAIN RELIEVING OINTMENT

CONCENTRATED

INGREDIENTS AND APPEARANCE

TIGER BALM RED EXTRA STRENGTH

camphor (synthetic) and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66403-308
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	110 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Cajuput Oil (UNII: J3TO6BUQ37)
Chinese Cinnamon Oil (UNII: A4WO0626T5)
Clove Oil (UNII: 578389D6D0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66403-308-25	1 in 1 BOX	01/25/2002
1		18 g in 1 JAR; Type 0: Not a Combination Product
2	NDC:66403-308-35	1 in 1 BOX	01/25/2002
2		18 g in 1 JAR; Type 0: Not a Combination Product
3	NDC:66403-308-23	1 in 1 BOX	01/25/2002
3		4 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/25/2002

Labeler - Tiger Balm (Malaysia) Sdn. Bhd. (652104126)

Name	Address	ID/FEI	Business Operations
Establishment
Tiger Balm (Malaysia) Sdn. Bhd.		652104126	MANUFACTURE(66403-308)

Revised: 12/2019

Document Id: 6a2ab4cb-4105-4739-8c54-21a226ac8577

Set id: e2e3d225-1503-4391-9c35-1ef707e6264c

Version: 3

Effective Time: 20191212

Search by Drug Name or NDC

NDC 66403-0308-25 Tiger Balm Red 110; 100 mg/g; mg/g Details

Tiger Balm Red 110; 100 mg/g; mg/g

Product Information

Package

Package Images

NDC 66403-0308-25 (66403030825)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e2e3d225-1503-4391-9c35-1ef707e6264c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other Information

Inactive Ingredients

Questions/Comments

PRINCIPAL DISPLAY PANEL - 18 g Carton

INGREDIENTS AND APPEARANCE

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