Label: BASE NUMB TOPICAL ANORECTAL- lidocaine cream
- Label RSS
- Share
-
Contains inactivated NDC Code(s)
NDC Code(s): 80327-000-01 - Packager: Joonem LLC
- 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 July 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Indications:
-
Warnings:
- If condition worsens or does not improve within 7 days, consult a doctor.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, consult a doctor promptly.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
- Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other, symptoms develop or increase, discontinue use and consult a doctor.
-
Directions:
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.
- Children under 12 years of age:
- consult a doctor
-
Inactive Ingredients:
Aloe Vera, Chamomile, Tea Trea Oil, Clove Oil, Hemp Seed Oil, Glycerin, Stearic Acid, EDTA, Arcel 165, Carbopol U-10, Cetyl Alcohol, BHT, Cetearyl Alcohol, Cetearyl Glucoside, Phenoxyethanol, Ethylhexylglycerin, Cyclopentasiloxane, Phenyl Trimethicone, Dimethiconol, C12-15 Alkyl Benzoate, Dimethicone Crosspolymer, Caustic Soda/Sodium Hydroxide, Capric Caprylic Triglyceride, DM Water
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
BASE NUMB TOPICAL ANORECTAL
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80327-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) CLOVE OIL (UNII: 578389D6D0) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) EDETIC ACID (UNII: 9G34HU7RV0) CETYL ALCOHOL (UNII: 936JST6JCN) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80327-000-01 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 09/01/2020 Labeler - Joonem LLC (117633878)
