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  5. Label Information: Tiger Balm Pain Relieving Hydrogel Large

FDA Label for Tiger Balm Pain Relieving Hydrogel Large

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS/COMMENTS
    13. PRINCIPAL DISPLAY PANEL - 4 PATCH POUCH LABEL

Tiger Balm Pain Relieving Hydrogel Large 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


Otc - Purpose



Active IngredientsPurpose
DL-Camphor 230 mg/patchTopical Analgesic
L-Menthol 70 mg /patchTopical Analgesic
Capsicum Extract 46 mg/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 clear 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 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

* Please review the disclaimer below.