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HYSAN HUO LU MEDICATED by HYSAN PHARMACEUTICAL CO LTD

Dosage form: oil
Ingredients: METHYL SALICYLATE 40g in 100mL, MENTHOL 36g in 100mL, CAMPHOR (SYNTHETIC) 10g in 100mL
Labeler: HYSAN PHARMACEUTICAL CO LTD
NDC Code: 63255-010

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

Methyl Salicylate 40%

Menthol 36%

Camphor 10%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches, muscles and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

  • external use only
  • use only as directed

Do not use

  • on opened wounds
  • on damaged skin

When using this product

  • avoid contact with the eyes
  • do not bandage tighly

Stop use and ask a doctor if

  • a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • adults and children 12 years and older, clean and dry the affected area, apply and massage gently not more than 3 to 4 times daily
  • children under 12 years of age, consult a doctor before using

Inactive ingredients

Eucalyptus Oil. Turpentine Oil

HYSAN HUO LU MEDICATED 
methyl salicylate, menthol, camphor (synthetic) oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63255-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE40 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL36 g  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
TURPENTINE OIL 
Packaging
#Item CodePackage Description
1NDC:63255-010-0150 mL in 1 BOTTLE, GLASS
2NDC:63255-010-023 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/04/2013
Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
Establishment
NameAddressID/FEIOperations
HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-010)

Document Id: f88ff856-323d-40f6-8676-8e8e3115b823
Set id: edd12577-e5da-40c5-a0ce-2d8d9f442fc9
Version: 5
Effective Time: 20140206
 
HYSAN PHARMACEUTICAL CO LTD

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Medically reviewed on Feb 6, 2019

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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