TIGER BALM PAIN RELIEVING HYDROGEL LARGE (camphor- synthetic, levomenthol, and capsicum patch

Tiger Balm Pain Relieving Hydrogel by

Drug Labeling and Warnings

Tiger Balm Pain Relieving Hydrogel by is a Otc medication manufactured, distributed, or labeled by Haw Par Healthcare Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
DL-Camphor 230 mg/patch	Topical Analgesic
L-Menthol 70 mg /patch	Topical Analgesic
Capsicum Extract 46 mg/patch	Topical Analgesic

Uses

For temporary relief of pains.

Warnings

FOR EXTERNAL USE ONLY

When using this product

• Use only as directed
• Do not get into eyes or on mucous membranes
• Do not apply to wounds, damaged or irritated skin
• Do not bandage or cover with any type of wrap except clothing
• Do not use with a heating pad or apply external heat
• Do not use 1 hour prior to bathing or within 30 minutes after bathing

Stop use and ask a doctor if

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days
• Symptoms clear up and occur again within a few days

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 Poison Control Center right away.

Directions

• Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
• Children under 12 years, consult doctor before use
• How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
• Reseal pouch containing unused patches

Other Information

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredients

Carboxymethylcellulose Sodium, Eucalyptus Oil, Glycerin, Mentha Oil, Methyl Acrylate and 2-Ethylhexyl Acrylate Copolymer, Purified Water, Polysorbate 80, PVA Solution, Silicon Dioxide, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Monooleate, Sorbitol Solution, Tartaric Acid

Questions/Comments

(925) 292-3888

PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Label

NDC: 66761-324-04

LARGE

TIGER BALM®

TIGER BALM®
PAIN RELIEVING
HYDROGEL PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

• Stretchable
• Long Lasting
• Convenient And Not Messy
• It Works!

4 PATCHES (8 x 4 inches each)

INGREDIENTS AND APPEARANCE

TIGER BALM PAIN RELIEVING HYDROGEL   LARGE
camphor (synthetic), levomenthol, and capsicum patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	230 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	70 mg
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	46 mg

Inactive Ingredients
Ingredient Name	Strength
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
eucalyptus oil (UNII: 2R04ONI662)
glycerin (UNII: PDC6A3C0OX)
methyl acrylate (UNII: WC487PR91H)
water (UNII: 059QF0KO0R)
polysorbate 80 (UNII: 6OZP39ZG8H)
silicon dioxide (UNII: ETJ7Z6XBU4)
sorbitan monooleate (UNII: 06XEA2VD56)
sorbitol (UNII: 506T60A25R)
tartaric acid (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-324-04	1 in 1 BOX	01/01/2017
1		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2017

Labeler - Haw Par Healthcare Ltd. (659207039)