LidoER by Diabetic Supply of Suncoast, Inc. / Pharma Supply, Inc. LIDOER

LidoER by

Drug Labeling and Warnings

LidoER by is a Otc medication manufactured, distributed, or labeled by Diabetic Supply of Suncoast, Inc., Pharma Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ingredient: Purpose
• 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 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71814-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71814-121-04	113 g in 1 JAR; Type 0: Not a Combination Product	06/01/2018	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2018	02/28/2023

Labeler - Diabetic Supply of Suncoast, Inc. (043081723)

Registrant - Pharma Supply, Inc. (122925436)

Revised: 11/2022

Document Id: ee279fc1-02f6-2d5f-e053-2995a90aeedc

34390-5

Set id: af4d337f-4f79-14c5-e053-2a95a90afb95

Version: 6

Effective Time: 20221123