Label: LIDOCAINE ANORECTAL- lidocaine cream
- NDC Code(s): 39328-025-15, 39328-025-30
- Packager: Patrin Pharma 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 April 14, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
When using this product
- Avoid contact with eyes
- Do not exceed recommended dosage unless directed by a doctor
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Directions
- When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
- Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
- Children under 12 years of age: Consult a doctor
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton
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INGREDIENTS AND APPEARANCE
LIDOCAINE ANORECTAL
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39328-025 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 50 mg in 1 g Inactive Ingredients Ingredient Name Strength Benzyl Alcohol (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) Isopropyl Myristate (UNII: 0RE8K4LNJS) Polysorbate 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Trolamine (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:39328-025-15 1 in 1 CARTON 11/01/2018 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:39328-025-30 1 in 1 CARTON 11/01/2018 2 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/01/2018 Labeler - Patrin Pharma Inc. (806841677)