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 LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRO PLUS- lidocaine hcl, tetracaine hcl 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

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

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

SP2261-.875

PRO PLUS 
lidocaine hcl, tetracaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-002
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 29.5735 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	20 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: 80069-002-01	25.8768 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2006	03/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/03/2006	03/16/2021

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
Kirkman Group, Inc		095275447	manufacture(80069-002)

Revised: 8/2020

Document Id: 2081fcf7-48f7-40f5-b7a1-a033dab009dd

34390-5

Set id: 3c959382-27c7-4f7d-9c48-2106948e7225

Version: 3

Effective Time: 20200814