SHEXIANG ZHUANGGU GAO- camphor, menthol, methyl salicylate plaster

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Camphor 1.91% External Analgesic, Menthol 2.54%: External Analgesic, Methyl Salicylate 1.62%: External Analgesic
Available from:
International Nature Nutraceuticals
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of minor aches and pains of muscles and joints due to: Simple backache Arthritis Strains Bruises Sprains On wounds On irritated or damaged skin If the appearance of this product has changed In excess of 12 hours If known sensitivity this product Otherwise than as Directed Pregnant, or taking other medications 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 When Using for pain of arthritis Pain persists for more than 10 days redness is present In conditions affecting children under 12 years of age
Authorization status:
OTC monograph not final
Authorization number:
51367-033-10

SHEXIANG ZHUANGGU GAO- camphor, menthol, methyl salicylate plaster

International Nature Nutraceuticals

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

Camphor 1.91% External Analgesic

Menthol 2.54%: External Analgesic

Methyl Salicylate 1.62%: External Analgesic

Us es

For the temporary relief of minor aches and pains of muscles and joints due to:

Simple backache

Arthritis

Strains

Bruises

Sprains

Do Not Use

On wounds

On irritated or damaged skin

If the appearance of this product has changed

In excess of 12 hours

If known sensitivity this product

Otherwise than as Directed

Ask a doctor or pharmacist before use if you are:

Pregnant, or taking other medications

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

When Using for pain of arthritis

Pain persists for more than 10 days

redness is present

In conditions affecting children under 12 years of age

Keep Out of Reach of Children

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

Warnings :

For External Use Only

Directions

Adults and Children 12 years of age and older: apply one or two plasters to affected area once a day,

remove after 12 hours

Children 2 to 12 years of age and adults with compromised health: use only the guidance of a doctor

Children under 2 years of age: do not use

Allergy Alert:

This product contains natural rubber latex which may cause allergic reactions

Other Information:

Keep container tightly closed

Store below 20C in a dry area.

Inactive Ingredients

STAR ANISE

ANGELICA DAHURICA ROOT

ATRACTYLODES LANCEA ROOT

ANGELICA SINENSIS ROOT

GINGER

CYNANCHUM PANICULATUM WHOLE

KAEMPFERIA GALANGA ROOT

GERANIUM WILFORDII WHOLE

CYATHULA OFFICINALIS ROOT

MUSCONE

CHONDROITIN SULFATE (PORCINE)

BORNEOL

NATURAL LATEX RUBBER

ROSIN

ZINC OXIDE

PETROLATUM

LANOLIN

PARAFFIN

Packaging

SHEXIANG ZHUANGGU GAO

camphor, menthol, methyl salicylate plaster

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5136 7-0 33

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) - UNII:N20 HL7Q9 41)

CAMPHOR (NATURAL)

30 .53 mg

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

40 .71 mg

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

25.9 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STAR ANISE (UNII: XKC16 57P78 )

ANGELICA DAHURICA RO O T (UNII: 1V6 3N2S9 72)

ATRACTYLO DES LANCEA RO O T (UNII: CAZ6 28 2J2O)

ANGELICA SINENSIS RO O T (UNII: B6 6 F4574UG)

GINGER (UNII: C5529 G5JPQ)

CYNANCHUM PANICULATUM WHO LE (UNII: T14ONG8 D7H)

KAEMPFERIA GALANGA RO O T (UNII: 7B7U9 D12AI)

International Nature Nutraceuticals

GERANIUM WILFO RDII WHO LE (UNII: QXI9 74Y72W)

CYATHULA O FFICINALIS RO O T (UNII: BRM37UP34O)

MUSCO NE (UNII: UPS3C6 CV36 )

CHO NDRO ITIN SULFATE ( PO RCINE) (UNII: V5E8 ELO4W9 )

BO RNEO L (UNII: M8 9 NIB437X)

NATURAL LATEX RUBBER (UNII: 2LQ0 UUW8 IN)

RO SIN (UNII: 8 8 S8 7KL8 77)

ZINC O XIDE (UNII: SOI2LOH54Z)

PETRO LATUM (UNII: 4T6 H12BN9 U)

LANO LIN (UNII: 7EV6 5EAW6 H)

PARAFFIN (UNII: I9 O0 E3H2ZE)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:5136 7-

0 33-10

10 in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe,

patch, etc.)

0 4/15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/15/20 19

Labeler -

International Nature Nutraceuticals (006106879)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Inner Mo ngo lia Ho rqin Pharmaceutical Co .,Ltd

548 6 3548 3

ma nufa c ture (5136 7-0 33)

Revised: 4/2019

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