Label: BUNNIES BUM ANORECTAL NUMBING- lidocaine spray
- NDC Code(s): 84308-173-05
- Packager: FloCal Distributors LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 8, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only.
Flammable. Keep away from excessive heat or open flame.
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
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly and gently pat dry. Spray affected area, wash hands after 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BUNNIES BUM ANORECTAL NUMBING
lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84308-173 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 ALCOHOL (UNII: 3K9958V90M) CARBOMER 940 (UNII: 4Q93RCW27E) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHAMOMILE (UNII: FGL3685T2X) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CUCUMBER (UNII: YY7C30VXJT) DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) ASCORBIC ACID (UNII: PQ6CK8PD0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84308-173-05 142 g in 1 CAN; Type 0: Not a Combination Product 06/02/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 06/02/2025 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(84308-173)

