MEDICATED OIL- menthol, methyl salicylate oil

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

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Active ingredient:
Menthol 8% Methyl Salicylate 26%
Available from:
Luoyang Muchun Pharmaceutical Co, Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Menthol      Topical Analgesic Methyl Salicylate      Topical Analgesic For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises. Condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. People with allergic conditution consult a doctor before using.
Authorization status:
OTC monograph not final
Authorization number:
72323-001-10, 72323-001-30

MEDICATED OIL- menthol, methyl salicylate oil

Luoyang Muchun 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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Luoyang Muchun Pharmaceutical Co, Ltd

Active Ingredients

Menthol 8%

Methyl Salicylate 26%

Purpos e

Menthol Topical Analgesic

Methyl Salicylate Topical Analgesic

Us es

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple

backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and older: Apply to the affected area 3 to 4 times daily. Children

under 12 years of age: Do not use, consult a doctor.

Warning

For External Use Only.

When Using This Product

Use only as directed.

Do not get into eyes or mucous membranes.

Do not apply to wound or damaged skin.

Do not bandage tightly.

Pregnant or lactating women consult a doctor before using.

Stop Use and Ask a Doctor If

Condition worsens.

Symptoms persist for more than 7 days or clear up and occur again within a few days.

People with allergic conditution consult a doctor before using.

Other Information

Keep bottle tightly closed and store at temperature below 25°C (77°F).

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Manufactured by

Luoyang Muchun Pharmaceutical Co, Ltd.

Distributed by Magic Wand (Beijing) Trading Co, Ltd

1501-1502, 15th F, Building 3, No. 3 Zhonghe Road, Fengtai District, Beijing 100070

Made in China

Inactive Ingredients

CLOVE OIL, EUCALYPTUS GLOBULUS LEAF, CINNAMON OIL, PARAFFIN, ROSE OIL,

PEPPERMINT OIL

Drug Facts

MEDICATED OIL

menthol, methyl salicylate oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72323-0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

MENTHOL

8 g in 10 0 mL

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

METHYL SALICYLATE

26 g in 10 0 mL

Luoyang Muchun Pharmaceutical Co, Ltd

Inactive Ingredients

Ingredient Name

Stre ng th

CLO VE O IL (UNII: 578 38 9 D6 D0 )

EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 )

CINNAMO N O IL (UNII: E5GY4I6 YCZ)

PARAFFIN (UNII: I9 O0 E3H2ZE)

RO SE O IL (UNII: WUB6 8 Y35M7)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:72323-0 0 1-

1 in 1 BOX

0 6 /15/20 18

1

NDC:72323-0 0 1-

10 mL in 1 BOTTLE, GLASS; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

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 6 /15/20 18

Labeler -

Luoyang Muchun Pharmaceutical Co, Ltd (526916382)

Revised: 7/2018

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