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.

label
PRO PLUS 
lidocaine hcl, tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 29.5735 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride10 mg  in 29.5735 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80069-009-0125.8768 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/202104/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/10/202104/25/2024
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-009)

Revised: 4/2024
 
Dermal Source, Inc.