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

Hua Tuo Huo Lu Oil by

Drug Labeling and Warnings

Hua Tuo Huo Lu Oil 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 40%

Menthol 36%

Camphor 10%

PURPOSE

Purpose:

External Analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches, 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

INACTIVE INGREDIENT

Inactive ingredients

Eucalyptus Oil, Turpentine Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	40 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	36 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
TURPENTINE OIL (UNII: C5H0QJ6V7F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63255-011-01	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/27/2013	08/01/2021
2	NDC: 63255-011-02	3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/27/2013	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/27/2013	08/01/2021

Labeler - Hysan Pharmaceutical Co Ltd (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
Hysan Pharmaceutical Co Ltd		666427133	manufacture(63255-011)