TLC PLUS ANESTHETIC G- lidocaine gel gel

TLC Plus Anesthetic G by

Drug Labeling and Warnings

TLC Plus Anesthetic G by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: adults and children over 12 years

• apply a thin layer to affected area every 6 to 8 hours
• after applying, wash hands with soap and water

ACTIVE INGREDIENT

Active Ingredient

Lidocaine HCl 4%

STOP USE

Stop Use and ask a doctor if:

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more then 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.

ASK DOCTOR

Stop Use and ask a doctor if:

condition worsens
redness is present
irritation develops
symptoms persist for more then 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.

DO NOT USE

Do not use

• on large areas of the body or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

INDICATIONS & USAGE

Uses

For the temporary relief of pain associated with minor skin procedures

PURPOSE

Topical Anesthetic

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional

before use

WARNINGS

Warnings

For external use only

Do not use

• on large areas of the body or on red, irritated or swollen skin
• on puncture wounds
• for more than one week wihout consulting a doctor

INACTIVE INGREDIENT

Aloe Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol, Glycerin,

KEEP OUT OF REACH OF CHILDREN

Keep ot of reach of children

and pets.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TLC PLUS ANESTHETIC G 
lidocaine gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.36 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-416-02	59 g in 1 JAR; Type 0: Not a Combination Product	07/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/28/2017

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-416)