PAIN RELIEF PATCHES by PLANET (ANHUI) MEDICAL PRODUCTS CO., LTD

PAIN RELIEF PATCHES by

Drug Labeling and Warnings

PAIN RELIEF PATCHES by is a Otc medication manufactured, distributed, or labeled by PLANET (ANHUI) MEDICAL PRODUCTS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF PATCHES- lidocaine pain relief patch patch 
PLANET (ANHUI) MEDICAL PRODUCTS 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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Lidocaine 4%

Topical anesthetic

For temporary relief of pain

For external use only

Do not use

• more than 1 patch at a time
• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

• localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

ask a health professional before use

If swallowed, get medical help or contact a Poison Control Center right away.

Adults and children 12 years of age and over:

• clean and dry affected area
• remove film from patch and apply to the skin
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• patch should not be applied longer than an 8 hour period

Children under 12 years of age: consult a doctor

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tween 80, Water

1-888-DYNAREX

PAIN RELIEF PATCHES 
lidocaine pain relief patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75568-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K90 (UNII: RDH86HJV5Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
KAOLIN (UNII: 24H4NWX5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75568-009-40	40 mg in 1 PATCH; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2020	05/01/2023

Labeler - PLANET (ANHUI) MEDICAL PRODUCTS CO., LTD (554530224)

Establishment
Name	Address	ID/FEI	Business Operations
PLANET (ANHUI) MEDICAL PRODUCTS CO., LTD		554530224	manufacture(75568-009)

Revised: 5/2023

Document Id: fc61e4ea-12df-6e7a-e053-6294a90aa70a

34390-5

Set id: adcc77d1-41b5-6c3c-e053-2995a90a1466

Version: 3

Effective Time: 20230523