HYSAN HUA TUO HUO LU (methyl salicylate, camphor- synthetic oil

HYSAN HUA TUO HUO LU by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

​Drug Facts

Active Ingredients

​Methyl Salicylate 37%

Camphor 10%

PURPOSE

​Purpose

​External Analgesic

INDICATIONS & USAGE

​Uses

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

• simple backache
• arthritis
• strains
• sprains
• bruises

WARNINGS

​warnings​

• external use only
• use only as directed

DO NOT USE

​Do not use​

• on opened wounds
• on damaged skin

WHEN USING

​When using this product​

• avoid contact with the eyes
• do not bandage tighly

STOP USE

​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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

​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 SAFETY INFORMATION

Other information​

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

INACTIVE INGREDIENT

Inactive ingredients​

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

QUESTIONS

Question or comments?​

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYSAN HUA TUO HUO LU 
methyl salicylate, camphor (synthetic) oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-121
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: 63255-121-01	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2017
2	NDC: 63255-121-02	3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2017

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
HYSAN PHARMACEUTICAL CO LTD		666427133	manufacture(63255-121)