ZYLOTROL PLUS- lidocaine 4%, menthol 1%, isopropyl alcohol kit

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:

Whitestone Products LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of pain First Aid Antiseptic For preparation of the skin prior to an injection - Do not use with electrocautery procedures - Do not use in the eyes - Do not apply to irritated skin - Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician. - Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ZYLOTROL PLUS- LIDOCAINE 4%, MENTHOL 1%, ISOPROPYL ALCOHOL
WHITESTONE 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._
----------
ZYLOTROL PLUS
LIDOCAINE 4% / MENTHOL 1% PATCH
ACTIVE INGREDIENTS:
Lidocaine 4.00%
Menthol 1.00%
Topical Anesthetic
External Analgesic
USES:
For temporary relief of pain
WARNINGS:
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.
DO NOT USE
in large quantities, particularly over raw surfaces or blistered
areas.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional 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 OVER 12 YEARS):
Clean and dry affected area.
Remove patch from backing and apply to affected area.
Use only one patch at a time, and maximum of four patches / day.
Leave patch on affected area for up to 8 hours
Do not use patches for longer than five consecutive days,
Children under 12 should consult physician prior to use.
INACTIVE INGREDIENTS:
Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate
80, Tartaric Acid,
Dihydroxyaluminium Aminoacetate, Methylparaben
Store below 25 degrees Celsius, Avoid directe sunlight.
ISOPROPYL ALCOHOL 70% PREP PADS
ACTIVE INGREDIENT
Isopropyl Alcohol 70% v/v
PURPOSE
First Aid Antiseptic
USE
For preparation of the skin prior to an injection
WARNINGS
For external use only
Flammable, keep away from fire or flame
Do not use with electrocautery procedures
Do not use in the eyes
Do not apply to irritated skin
Stop use if pain, irritation, redness, or swelling occurs, discontinue
use and consult a
physician.
KEEP OUT FROM REACH OF CHILDREN. If swallowed, get medical help or
contact a
Poison Contro