POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
25-01-2024

Aktiv ingrediens:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Tilgjengelig fra:

Fabrication Enterprises

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/ or sprains.

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                POINT RELIEF COLD SPOT PAIN RELIEVING- MENTHOL GEL
FABRICATION ENTERPRISES
----------
POINT RELIEF COLD SPOT PAIN RELIEVING GEL
_DRUG FACTS_
_ACTIVE INGREDIENTS:_
menthol - USP 12%
_PURPOSE:_
external analgesic
_USES:_
For temporary relief of minor aches and pains of the muscles and
joints associated with
simple backache, arthritis, bruises, strains, and/ or sprains.
_WARNINGS:_
For external use only
Avoid contact with eyes
DO NOT APPLY
to open wounds or damaged skin
If symptoms persist for more than sevan days, discontinue use and
consult
physician
KEEP OUT OF REACH OF CHILDREN
If swallowed, consult physician
Do not bandage tightly
_DIRECTIONS:_
Apply directly to affected area. Do not use more than four fimes per
day.
_OTHER INGREDIENTS:_
aqua (deionized water), arnica montana flower (arnica) extract,
boswellia serrata
extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus
oil, glycyrrhiza
glabra (licorice) extract, ilex paraguariensis leaf (yerba mate)
extract, mentha piperita
(peppermint) oil, methyl salicylate, MSM (dimethyl sulfone),
polysorbate-80, propyl
paraben, propylene glycol, SD-alcohol 40B, triethanolamine
POINT RELIEF COLD SPOT PAIN RELIEVING GEL, 120ML (51452-035-01)
POINT RELIEF COLD SPOT PAIN RELIEVING GEL, 475ML (51452-035-02)
POINT RELIEF COLD SPOT PAIN RELIEVING GEL, 3.8L (51452-035-03)
POINT RELIEF COLD SPOT PAIN RELIEVING GEL, 420ML(HANDS
FREE)(51452-035-04)
POINT RELIEF COLD SPOT PAIN RELIEVING GEL, 950ML (51452-035-05)
POINT RELIEF COLD SPOT PAIN RELIEVING
menthol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:51452-035
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
120 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Fabrication Enterprises
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOL
                                
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