VENIA PATCH PREMIUM PAIN PATCH- menthol, lidocaine patch

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
19-08-2015

Aktiv ingrediens:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Tilgjengelig fra:

Alivio Medical Products, LLC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Purpose Topical anesthetic Topical anesthetic Uses: For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                VENIA PATCH PREMIUM PAIN PATCH- MENTHOL, LIDOCAINE PATCH
ALIVIO MEDICAL PRODUCTS, LLC
_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 4 %
Lidocaine 4 %
PURPOS E
Topical anesthetic
Topical anesthetic
US ES :
For the temporary relief of minor aches and muscle pains associated
with arthritis, simple
backache, strains, muscle soreness and stiffness
WARNINGS :
-Only for external use. Use only as directed or by a health
professional.
-Do not use: on open wounds, cuts, damaged or infected skin as well as
in the eyes, mouth,
genitals, or any other mucous membranes.
-Do not cover with bandage.
-Keep out of reach of children.Consult physician for children under
12.
-Consult your physician: if pregnant or pain persists or worsens.
DIRECTIONS :
-Adults and children 12 years and over. Apply patch to affected area 1
to 2 times daily or
as directed.
-Instructions for use:
-Clear and dry the affected area
-Open pouch and remove one patch
-Remove any protective film and apply directly to affected area of
pain
-Wash hands with soap and water after applying patch
-Reseal pouch containing unused patches after each use
Keep out of reach of children. Consult physician for children under 12
OTHER INGREDIENTS:
Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2 Ethylhexyl
Acrylate, Glycerin, Isopropyl
Myristate, Methyl Acrylate, Nonoxynol 30, Polyacrylate, Polyacrylic
Acid, Polysorbate 80, Sorbitan
Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water
VENIA PATCH PREMIUM PAIN PATCH
menthol, lidocaine patch
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 512-70 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED
FORM -
UNII:L7T10 EIP3A)
MENTHOL, UNSPECIFIED
FOR
                                
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