PHARMACYS PRESCRIPTION- analgesic gel

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

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Active ingredient:
MENTHOL 1%
Available from:
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain relieving gel for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Authorization status:
OTC monograph final
Authorization number:
76176-017-08

PHARMACYS PRESCRIPTION- analgesic gel

NINGBO LIYUAN DAILY CHEMICAL PRODUCTS 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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DRUG FACTS

ACTIVE INGREDIENTS

MENTHOL 1%

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 not use, consult a doctor.

PURPOSE

Pain relieving gel

PURPOSE

for the temporary relief of minor aches and pains of muscles and joints associated with simple

backache, arthritis, strains, bruises and sprains.

Warnings

For external use only.

When using this product, avoid contact with eyes, do not bandage tightly, do not apply to wounds or

damaged skin, do not use with heating pads or other heating devices.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up

and occur again with a few days.

Keep out of reach of children

INACTIVE INGREDIENTS

carbomer, isopropyl alcohol, nonylphenylpolyoxyethylene ether, camphor, kathon CG, FD&C blue

no.1, triethanolamine, water

PHARMACYS PRESCRIPTION

NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD

analgesic gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 176 -0 17

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

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

8 7 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:76 176 -0 17-0 8

227 g in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 1/0 1/20 14

Labeler -

NINGBO LIYUAN DAILY CHEMICAL PRODUCT S CO LT D (530766098)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD

530 76 6 0 9 8

ma nufa c ture (76 176 -0 17)

Revised: 7/2014

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