PAIN RELIEF GEL-PATCH- lidocaine, menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

R & Y Group, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic (Lidocaine) Topical Analgesic (Menthol) for temporary relief of pain - More than 1 patch at a time - If you are allergic to any ingredients of this product - On wounds or damaged skin - In large quantities, particularly over raw surfaces or blistered areas - Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering - Conditions worsen - Symptoms clear up and occur again within a few days - Symptoms persist for more than 7 days

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEF GEL-PATCH- LIDOCAINE, MENTHOL PATCH
R & Y GROUP, 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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THERAICE LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 7 PATCHES
_ACTIVE INGREDIENTS_
Lidocaine 4% w/w ...... Purpose: Topical Anesthetic
Menthol 1% w/w ...... Purpose: Topical Analgesic
_PURPOSE_
Topical Anesthetic (Lidocaine)
Topical Analgesic (Menthol)
_USE_
for temporary relief of pain
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
More than 1 patch at a time
If you are allergic to any ingredients of this product
On wounds or damaged skin
In large quantities, particularly over raw surfaces or blistered areas
WHEN USING THIS PRODUCT
Use only as directed
Avoid contact with the eyes, mucous membranes or rashes
Do not bandage tightly
STOP USE AND CONSULT A DOCTOR IF
Localized skin reactions occur, such as a rash, itching, redness,
irritation, pain,
swelling and blistering
Conditions worsen
Symptoms clear up and occur again within a few days
TM
Symptoms persist for more than 7 days
IF PREGNANT OR BREAST-FEEDING,
ask a physician before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER.
Clean and dry affected area
Remove film from patch and apply to the skin
Apply to affected area not more than 3 to 4 times daily
Remove patch from the skin after 8-hour application at most
CHILDREN UNDER 12 YEARS OF AGE: Consult a physician
_OTHER INFORMATION_
Store at 68° - 77° F (20° - 25° C)
Store in a cool dry place away from direct sunlight
_INACTIVE INGREDIENTS_
Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin,
Hydroxyacetophenone,
Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate
80,
Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate,
Titanium Dioxide, Water
PACKAGE LABEL. PRINCIPAL DIS