BUNNIES BUM HEMORRHOIDAL NUMBING- lidocaine cream

Bunnies Bum Hemorrhoidal Numbing by

Drug Labeling and Warnings

Bunnies Bum Hemorrhoidal Numbing by is a Otc medication manufactured, distributed, or labeled by FloCal Distributors LLC, Derma Care Research Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5%

PURPOSE

Topical anesthetic

INDICATIONS & USAGE

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

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

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

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

INGREDIENTS AND APPEARANCE

BUNNIES BUM HEMORRHOIDAL NUMBING 
lidocaine cream

Product 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)