Drug Facts - For use by licensed professionals only

Pro Plus by

Drug Labeling and Warnings

Pro Plus by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., KIRKMAN GROUP, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRO PLUS- lidocaine hcl, tetracaine hcl cream 
Dermal Source, Inc.

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Drug Facts - For use by licensed professionals only.

• Active Ingredients (in each cc): Purpose
• Lidocaine HCl 5%: Topical Anesthetic
• Tetracaine HCl 1%: Topical Anesthetic

Uses: External Use Only on Intact Skin. Temporarily relieves pain due to tattooing 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 within a few days, discontinue use of this 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 or until anesthetic effect occurs. Remove and cleanse skin. Repeat as needed up to three times a day.

Inactive Ingredients: Purified Water, Glycerol Monostearate, Petrolatum, Stearic Acid, Cetyl Alcohol, Hydroxyethylcelluose, Triethanolamine, PEG 100 Stearate, Propyl Paraben, Methyl Paraben, and BHT.

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

Questions? Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

PREMIUM

PRO PLUS

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

NDC: 80069-009-01

NDC Drug Facts - For use by licensed professionals only.

PRO PLUS 
lidocaine hcl, tetracaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	50 mg  in 29.5735 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	10 mg  in 29.5735 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Petrolatum (UNII: 4T6H12BN9U)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)
Trolamine (UNII: 9O3K93S3TK)
Peg-100 Stearate (UNII: YD01N1999R)
Propylparaben (UNII: Z8IX2SC1OH)
Methylparaben (UNII: A2I8C7HI9T)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-009-01	25.8768 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2021	04/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/10/2021	04/25/2024

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
HTO Nevada, Inc. (dba Kirkman)		117115846	manufacture(80069-009)

Revised: 4/2024

Document Id: 415a1f0b-dc87-4800-9442-3b31d31fdd4e

34390-5

Set id: 147235d9-51c3-43a6-87c8-f38b78045d4a

Version: 4

Effective Time: 20240425