Label: BUNNIES BUM HEMORRHOIDAL NUMBING- lidocaine cream
- NDC Code(s): 84308-159-01
- Packager: FloCal Distributors LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 5, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only.
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs to ingredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return within a few days
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- 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.
-
INACTIVE INGREDIENT
Ascorbic acid, benzyl alcohol, boswellia serrata extract, bromelain, carbomer, cholesterol, curcuma long (turmeric) root extract, glucose, glycerin, hydrogenated lecithin, isopropyl myristate, panax ginseng root extract, polysorbate 80, propylene glycol, salix alba (willow) bark extract, tocopheryl acetate, triethanolamine, water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUNNIES BUM HEMORRHOIDAL NUMBING
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84308-159 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 BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TURMERIC (UNII: 856YO1Z64F) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ASIAN GINSENG (UNII: CUQ3A77YXI) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) CHOLESTEROL (UNII: 97C5T2UQ7J) TROLAMINE (UNII: 9O3K93S3TK) ASCORBIC ACID (UNII: PQ6CK8PD0R) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) BROMELAINS (UNII: U182GP2CF3) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SALIX ALBA BARK (UNII: 205MXS71H7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84308-159-01 28 g in 1 TUBE; Type 0: Not a Combination Product 07/08/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 07/08/2024 Labeler - FloCal Distributors LLC (128775688) Registrant - Derma Care Research Labs LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs LLC 116817470 manufacture(84308-159)