Lidogel™ Lidocaine HCI 2.8% Gel

Lidogel by

Drug Labeling and Warnings

Lidogel by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOGEL- lidocaine hci gel 
PureTek Corporation

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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Lidogel™

Lidocaine HCI 2.8% Gel

Active ingredient

Lidocaine HCI 2.8%

Purpose

Topical analgesic

Uses

• for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts,
  scrapes, insect bites, and minor skin irritat ion.

Warnings

For external use only

When using this product

• Avoid contact with the eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

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

Directions

• Adults and children 2 years and older- Apply to affected area not more than 3 to 4 times daily
• Children under 2 years- Consult a doctor

Use under the direction of a medical practitioner

How Supplied:

Lidogel ™ Pain Relieving Gel is supplied in a 3.5 oz (100 g) tube (NDC: 59088-452-07)

Other information

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid excessive heat.
• Do not use if package is damaged.

Keep this and all medication out of reach of children

Inactive ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Citric Acid, Hydroxyethylcellulose, Methylparaben, PEG-4, Propylene Glycol, Propylparaben, Purified Water

Questions or comments?

For questions or information call toll-free: 877-921-7873

Lidogel™

Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340

LIDOGEL 
lidocaine hci gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	28 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-452-07	100 g in 1 TUBE; Type 0: Not a Combination Product	07/08/2021	07/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/08/2021	07/08/2021

Labeler - PureTek Corporation (785961046)

Revised: 7/2021

Document Id: c7a64a0f-1153-3e12-e053-2995a90a7930

34390-5

Set id: c2e13ea2-7d2b-ebf8-e053-2995a90a474a

Version: 2

Effective Time: 20210721