Label: PRO PLUS- lidocaine hcl, tetracaine hcl cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 30, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT


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

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

  • WARNINGS

    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

    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.
  • WHEN USING

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

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

  • STORAGE AND HANDLING

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

  • QUESTIONS

    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
  • INGREDIENTS AND APPEARANCE
    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 Product04/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/10/2021
    Labeler - Dermal Source, Inc. (183535629)
    Establishment
    NameAddressID/FEIBusiness Operations
    HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-009)