LIDOZEN- lidocaine, menthol patch

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:

Beijing HKKY Medical Tech. Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

LIDOZEN- LIDOCAINE, MENTHOL PATCH
BEIJING HKKY MEDICAL TECH. CO., LTD.
_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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LIDOZEN PATCH
DRUG FACTS:
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.
PACKAGE LABELING:
LIDOZEN
lidocaine, menthol patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71073-203
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Beijing HKKY Medical Tech. Co., Ltd.
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
40 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
10 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCO