Lidozen by Beijing HKKY Medical Tech. Co., Ltd. Lidozen Patch

Lidozen by

Drug Labeling and Warnings

Lidozen by is a Otc medication manufactured, distributed, or labeled by Beijing HKKY Medical Tech. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71073-203-01	5 in 1 POUCH	11/21/2019	03/01/2020
1		1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/20/2019	03/01/2020

Labeler - Beijing HKKY Medical Tech. Co., Ltd. (544434817)

Revised: 3/2020

Document Id: a37beccb-2b66-4373-8f5e-3ad8902ca27d

34390-5

Set id: 4c50ded0-3255-4a15-b333-27a70b396f89

Version: 3

Effective Time: 20200301

 

Beijing HKKY Medical Tech. Co., Ltd.