NULIDO LIDOCAINE PATCH PLUS MENTHOL- lidocaine, menthol patch 
All Pharma 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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NULIDO Lidocaine Patch Plus Menthol

Drug Facts

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

Topical Anesthetic

USES

Temporary relief of minor pain

WARNINGS

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

  • Contact a physician prior to use.

WHEN USING:

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS Adults and children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

DIST. BY All Pharma LLC
Hialeah, FL 33016

nulidopatch

NULIDO LIDOCAINE PATCH PLUS MENTHOL 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53149-2200-115 in 1 POUCH07/01/2018
18 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2018
Labeler - All Pharma LLC (078572520)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(53149-2200)

Revised: 12/2017
Document Id: 0d6d7da3-62ed-4a36-9d63-e8f1b3812883
Set id: 3ae5277f-8974-41e2-ad68-801977d0e269
Version: 2
Effective Time: 20171229
 
All Pharma LLC