TheraICE Rx TM Lidocaine&Menthol Pain Relief Gel-Patch, 7 Patches

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

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 - Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - Conditions worsen - Symptoms persist for more than 7 days - Symptoms clear up and occur again within a few 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 RX LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 7 PATCHES
_ACTIVE INGREDIENT_
Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic
Menthol 1.0% w/w ...... Purpose: Topical analgesic
_PURPOSE_
Topical anesthetic (Lidocaine)
Topical analgesic (Menthol)
_USES_
For temporary relief of pain
_WARNINGS_
USE ONLY AS DIRECTED
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR
CLEAR
UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT
AND
CONSULT A PHYSICIAN
_WHEN USING THIS PRODUCT_
Use only as directed
Avoid contact with the eyes, mucous membranes or rashes
Do not bandage tightly
_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
_STOP USE AND CONSULT A DOCTOR IF_
Localized skin reactions occur, such as rash, itching, redness,
irritation, pain, swelling
TM
and blistering
Conditions worsen
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few 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_
_ADULT 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
_INACTIVE INGREDIENTS_
Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium
Polyacrylate, Polysorbate 80,
Mineral Oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone,
L(+)-Tartaric Acid,
Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaol