Label: LOCAL ANESTHETIC ANORECTAL CREAM- lidocaine cream
- NDC Code(s): 84767-001-01
- Packager: Make Labs LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 18, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- 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.
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Apply externally to the affected area up to 6 times a day.
- Children 12 and under, consult a physician prior to use.
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INACTIVE INGREDIENT
Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Cetearyl Alcohol, Ceteth-20, Carbomer, Cholesterol, Ethoxydiglycol, Lecithin, PPG-12/SMDI Copolymer, Propanediol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOCAL ANESTHETIC ANORECTAL CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84767-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SHEA BUTTER (UNII: K49155WL9Y) CHOLESTEROL (UNII: 97C5T2UQ7J) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) PROPANEDIOL (UNII: 5965N8W85T) POLYSORBATE 60 (UNII: CAL22UVI4M) JOJOBA OIL (UNII: 724GKU717M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84767-001-01 170 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 08/01/2024 Labeler - Make Labs LLC (126167088)