LIDOER- lidocaine hcl cream 
Diabetic Supply of Suncoast, Inc.

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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LIDOER

DRUG FACTS

Active ingredient and Purpose

Active ingredientPurpose
Lidocaine HCL 4%............................Topical analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. Avoid contact with the eyes.

Do not use

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 immediately.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other information

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

c9-11 alkane/cycloalkane, cetostearyl alcohol, imidurea, menthol, methylparaben, mineral oil, peg-150 stearate, petrolatum, polysorbate 60, propylene glycol, propylparaben, steareth-20, stearic acid, trideceth-12, water

Questions or comments?

(M-F) +1-888-469-3579

  • Advocatemeters.com

Distributed by:

Diabetic Supply of Suncoast, Inc.

PO Box 2102, Vega Alta, PR 00692

Principal Display Panel

LidoER

LIDOER 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71814-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHOL (UNII: L7T10EIP3A)  
PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARETH-20 (UNII: L0Q8IK9E08)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TRIDECETH-12 (UNII: YFY3KG5Y7O)  
WATER (UNII: 059QF0KO0R)  
C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71814-121-04113 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2018
Labeler - Diabetic Supply of Suncoast, Inc. (043081723)

Revised: 3/2021
Document Id: bc932c1c-25c9-7a0a-e053-2995a90ace3b
Set id: af4d337f-4f79-14c5-e053-2a95a90afb95
Version: 3
Effective Time: 20210302
 
Diabetic Supply of Suncoast, Inc.