OTC Medication Information: Kwan Loong

KWAN LOONG- methyl salicylate and menthol, unspecified form oil
Haw Par Healthcare Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients Purpose
Methyl Salicylate 35% External Analgesic
Menthol 16% External Analgesic

Uses

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

Warnings

FOR EXTERNAL USE ONLY.

When using this product

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not apply to open wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with 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
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later
  • Severe skin irritation occurs.

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

  • Adults and children 12 years of age or older, apply to the affected areas not more than 3 to 4 times daily
  • For children under 12 years old consult a doctor before use.

Other Information

This product may cause allergic reaction on some individuals. Test on small area before use.

Inactive Ingredients

Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.

Questions

(925) 292-3888

Manufactured by
Haw Par Healthcare Ltd.,
Singapore

PRINCIPAL DISPLAY PANEL — 57 ml Bottle Box

NDC 66761-311-22

KWAN LOONG ®

PAIN RELIEVING OIL

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

2 Fl. Oz. (57ml)

PRINCIPAL DISPLAY PANEL -- 57 ml Bottle Box
(click image for full-size original)
KWAN LOONG
methyl salicylate and menthol oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66761-311
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methyl salicylate (Salicylic Acid) Methyl salicylate 350 mg in 1 mL
Menthol, Unspecified Form (Menthol, Unspecified Form) Menthol, Unspecified Form 160 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Eucalyptus Oil
Spike Lavender Oil
Light Mineral Oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66761-311-01 1 BOTTLE in 1 BOX contains a BOTTLE
1 28 mL in 1 BOTTLE This package is contained within the BOX (66761-311-01)
2 NDC:66761-311-22 1 BOTTLE in 1 BOX contains a BOTTLE
2 57 mL in 1 BOTTLE This package is contained within the BOX (66761-311-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/01/2005
Labeler — Haw Par Healthcare Ltd. (659207039)
Establishment
Name Address ID/FEI Operations
Haw Par Healthcare Ltd. 659207039 MANUFACTURE (66761-311)
Establishment
Name Address ID/FEI Operations
Tiger Balm (Malaysia) Sdn. Bhd. 652104126 MANUFACTURE (66761-311)

Revised: 11/2018 Haw Par Healthcare Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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