TLC PLUS ANESTHETIC S- lidocaine spray

TLC Plus Anesthetic S by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

For the temporary relief of pain associated with minor skin procedures

WARNINGS

For external use only

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

WHEN USING

When using this product

• Use only as directed. Read and follow all directions and warnings on this label.
• rare cases of serious burns have been reported with products of this type
• do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch
• avoid contact with eyes and mucous membranes
• a transient burning sensation may occur upon application but generally disappears in several days

STOP USE

Stop use and ask 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets

• If swallowed, get medical help or contact a poison control center right away

INSTRUCTIONS FOR USE

Directions

adults and children over 12 years:

• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
• after applying, wash hands with soap and water

children 12 years or younger

• ask a doctor

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

QUESTIONS

877 2-TLC-PLUS

STATEMENT OF IDENTITY

TLC PLUS

Anesthetic

Spray

2 oz / 59 ml

DOSAGE & ADMINISTRATION

Directions

adults and children over 12 years:

• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
• after applying, wash hands with soap and water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TLC PLUS ANESTHETIC S 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-415
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-415-01	59 g in 1 BOTTLE, SPRAY; 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 final	part346	07/28/2017

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-415)