FDA Label for Tiger Balm Pain Relieving Hydrogel

View Indications, Usage & Precautions

Tiger Balm Pain Relieving Hydrogel Product Label

The following document was submitted to the FDA by the labeler of this product Haw Par Healthcare Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Manufactured by Haw Par Healthcare Ltd.,
Singapore under licence from Haw Par
Corporation Ltd.


Otc - Purpose



Active IngredientsPurpose
Camphor 160mg / patchTopical Analgesic
Menthol 48mg / patchTopical Analgesic
Capsicum Extract 32mg / patchTopical 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 clears up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


Directions



  • Adults and children 12 years and over apply to the 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

Other Information



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


Inactive Ingredients



Aluminium glycinate, eucalyptus oil, glycerin, hydrotalcite, kaolin, mentha oil, polysorbate 80, polyacrylic acid solution, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, sorbitol solution, water


Questions/Comments



(925) 292-3888


Principal Display Panel - 2 Patch Pouch



2 PATCH PACK
X WIDER SIZE*

*As compared to our
Regular Size Patch (4" x 2.75")

NDC 66761-354-02

TIGER BALM®

TIGER BALM®
PAIN RELIEVING
PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

* Please review the disclaimer below.