HYSAN HUO LU MEDICATED by HYSAN PHARMACEUTICAL CO LTD

HYSAN HUO LU MEDICATED by

Drug Labeling and Warnings

HYSAN HUO LU MEDICATED by is a Otc medication manufactured, distributed, or labeled by HYSAN PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYSAN HUO LU MEDICATED- methyl salicylate, camphor (synthetic) oil 
HYSAN PHARMACEUTICAL CO 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.

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Drug Facts

Active Ingredients

Methyl Salicylate 37%

Camphor 10%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches, pains of 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

Other information

• be stored below 28°C (82°F)
• closed tightly after used

Inactive ingredients

menthol, turpentine oil, eucalyptus oil, lavender oil, tolu balsam

Question or comments?

(626) 354 1819 M-F 9am to 5pm

HYSAN HUO LU MEDICATED 
methyl salicylate, camphor (synthetic) oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	37 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TOLU BALSAM (UNII: TD2LE91MBE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63255-131-01	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/15/2021	02/22/2021
2	NDC: 63255-131-02	3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/15/2021	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2021	02/22/2021

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
HYSAN PHARMACEUTICAL CO LTD		666427133	manufacture(63255-131)

Revised: 2/2021

Document Id: 68a9288f-10fa-48f1-acfc-8193c8580d89

34390-5

Set id: d1239ce6-0bd1-472c-a31f-6befc7499b06

Version: 3

Effective Time: 20210218