Label: PRO PLUS- lidocaine hcl, tetracaine hcl cream
- NDC Code(s): 80069-009-01
- Packager: Dermal Source, Inc.
- 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
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 04/10/2021 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-009)