Drug Facts - For use by licensed professionals only.

Super T by

Drug Labeling and Warnings

Super T by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., KIRKMAN LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER T- lidocaine hcl, tetracaine hcl, benzocaine cream 
Dermal Source, 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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Drug Facts - For use by licensed professionals only.

Active Ingredient  (in each cc)		Purpose
Lidocaine HCl	4%	Topical Anesthetic
Tetracaine HCl	2%	Topical Anesthetic
Benzocaine	12%	Topical Anesthetic

Uses: External Use Only on Intact Skin. Temporarily relieves pain due to tattooing, makeup or other pain sensitive procedures.

WARNINGS: Keep out of children's reach.
Keep out of eyes and mouth. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.

Do not use:

• If you have a history of severe liver disease or impairment.
• If you have a known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use and seek medical attention as needed. If condition worsens or does not improve in seven days, or clears up and occurs again with a few days, discontinue use of the product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.
• If pregnant or nursing.

Directions:  Sensitivity test advised prior to use.

Apply sparingly to affected area for 15-30 minutes. Remove and cleanse skin. Repeat as needed up to three times a day. Remove product before continuing with procedure.

Inactive Ingredients: Purified Water, Propylene Glycol, Ethyoxydiglycol, NF Emulsifying Wax, Polyacrylamide, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben, and EDTA.

Other information: Discard after expiration date. Store in cool, dark place.

Questions?
Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

SUPER
T

Topical Anesthetic for use before a Pain Sensitive procedure

7/8 oz. 

Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223

SP2267-.875

SUPER T 
lidocaine hcl, tetracaine hcl, benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	40 mg  in 1 g
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	20 mg  in 1 g
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	120 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
White Wax (UNII: 7G1J5DA97F)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Edetic Acid (UNII: 9G34HU7RV0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-006-01	24.805833 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2004	08/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2004	08/17/2021

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN GROUP, INC.		078525382	manufacture(80069-006)

Revised: 7/2021

Document Id: 96af1616-57ab-4fa9-bc5b-0147808ce7b8

34390-5

Set id: 99d325fb-ad01-4f89-90bd-dd2fc7b840e3

Version: 2

Effective Time: 20210716