STOPAIN CLINICAL- menthol, unspecified form gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Mevcut itibaren:

Troy Manufacturing, Inc.

Uygulama yolu:

TOPICAL

Reçete türü:

OTC DRUG

Terapötik endikasyonlar:

Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains

Yetkilendirme durumu:

OTC monograph not final

Ürün özellikleri

STOPAIN CLINICAL- MENTHOL, UNSPECIFIED FORM GEL
TROY MANUFACTURING, INC.
----------
ACTIVE INGREDIENT
Menthol 10.0%
PURPOSE
Topical Analgesic
USES
For the temporary relief of minor aches and pains of muscles and
joints associated with:
simple backache
arthritis
strains
bruises
sprains
WARNINGS
Avoid contact with eyes. FOR EXTERNAL USE ONLY.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
ADULTS AND CHILDREN OVER 12 YEARS:
ask a doctor. CHILDREN 12 YEARS OR YOUNGER:
apply directly onto affected area without the need to bandage
repeat if necessary, but do not apply more than 4 times daily.
INACTIVE INGREDIENTS
acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus
oil, glucosamine
sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone,
pentylene glycol,
peppermint oil, triethanolamine, water (USP)
PACKAGE LABELING
STOPAIN CLINICAL
menthol, unspecified form gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63936-0975
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL -
UNII:L7T10EIP3A)
MENTHOL, UNSPECIFIED
FORM
100 mg
in 1 g
INACTIVE INGREDIENTS
Troy Manufacturing, Inc.
INGREDIENT NAME
STRENGTH
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PEPPERMINT OIL (UNII: AV092KU4JH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:63936-
0975-5
5 g in 1 PACKET; Type 0: Not a Combination
Product
01/19/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M017
01/19/2017
LABELER -
Troy Manufacturing, Inc. (160075248)
REGISTRANT