ULTRA STRENGTH ZHENG GU SHUI- menthol and camphor liniment

ULTRA STRENGTH ZHENG GU SHUI by

Drug Labeling and Warnings

ULTRA STRENGTH ZHENG GU SHUI by is a Otc medication manufactured, distributed, or labeled by GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Menthol 4.1%
Camphor 4.1%

PURPOSE

Purpose
External analgesic
External analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ arthritis
■ strains
■ bruises
■ sprains
■ simple backache

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use
■ on wounds
■ on irritated or damaged skin
■ sensitive skin
■ with a heating pad
■ if pregnant
■ with, or at the same time as, other external analgesic products
■ if allergic to any ingredients of this product

WHEN USING

When using this product
■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

STOP USE

Stop use and ask a doctor if
■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ redness is present

PREGNANCY OR BREAST FEEDING

If pregnant, 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 hep or contact a Poison Control Center right away.

Do not use otherwise than as directed.

ADVERSE REACTIONS

Report any unexpected side effects from the use of this product to the FDA MedWatch Program.

DOSAGE & ADMINISTRATION

Directions
■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
■ Children under 2 years of age: do no use or consult a doctor.

STORAGE AND HANDLING

Other information
■ store at room temperature, 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

Inactive ingredients Alcohol, angelica dahurice root, angelica pubescens root, ardisia crenata root, ardisia gigantifolia root, artocarpus styracifolius root, calophyllum membranaceum whole, clematis chinensis root, curcuma phaeocaulis root, cyathulae officinalis root, cynanchum paniculatum root, eucommia ulmoides bark, kadsura coccinea whole, lasiobema championii stem, maclura cochinensis root, millettia pulchra root, periploca sepium root bark, piper hancei top, pothos repens root, reynoutria japonica root, sarcandra glabra top, securidaca inappendiculata root, spargnaium stoloniferum root, and spatholobus suberectus stem.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
■ You may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH ZHENG GU SHUI

MENTHOL AND CAMPHOR

NDC: 59321-056-02

EXTERNAL ANALGESIC

3.0 FL OZ (88 ML)

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH ZHENG GU SHUI 
menthol and camphor liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59321-056
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.1 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
ARDISIA CRENATA ROOT (UNII: 74U2K67MND)
ARDISIA GIGANTIFOLIA ROOT (UNII: 0E347O3NMS)
ARTOCARPUS STYRACIFOLIUS ROOT (UNII: L1D54XX58F)
CALOPHYLLUM MEMBRANACEUM WHOLE (UNII: M8FV4OUJ6F)
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
CURCUMA PHAEOCAULIS ROOT (UNII: P7PXC11S4S)
CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)
CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012)
EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)
KADSURA COCCINEA WHOLE (UNII: 81P4AE27JI)
LASIOBEMA CHAMPIONII STEM (UNII: U33KT97I2D)
MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)
MILLETTIA PULCHRA ROOT (UNII: TBW2M73EBN)
PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)
PIPER HANCEI TOP (UNII: AMU868N7QW)
POTHOS REPENS ROOT (UNII: L3VA8YE43K)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
SARCANDRA GLABRA TOP (UNII: 32E1WPH24S)
SECURIDACA INAPPENDICULATA ROOT (UNII: 0SVU07NNEC)
SPARGANIUM STOLONIFERUM ROOT (UNII: 66ZQ85S65H)
SPATHOLOBUS SUBERECTUS STEM (UNII: N51VZ363BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59321-056-02	1 in 1 BOX	04/04/2023
1		88 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2023

Labeler - GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (653862581)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD		653862581	manufacture(59321-056)