BUNNIES BUM SOOTHING HEMORRHOIDAL- glycerin, lidocaine, petrolatum, phenylephrine hcl cream

Bunnies Bum Soothing Hemorrhoidal by

Drug Labeling and Warnings

Bunnies Bum Soothing Hemorrhoidal 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

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

PURPOSE

Glycerin-Protectant

Lidocaine-Local anesthetic

Petrolatum-Protectant

Phenylephrine HCl Vasoconstrictor

INDICATIONS & USAGE

• For the temporary relief of pain, soreness, and burning
• Helps relieve the local itching and discomfort associated with hemorrhoids
• Temporarily shrinks hemorrhoidal tissue
• Temporarily provides a costing for the relief of anorectal discomforts
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

For external use only.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

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

• Adults: 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 4 times a day, especially at night, in the morning, or after each bowel movement.
• Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT

Aloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUNNIES BUM SOOTHING HEMORRHOIDAL 
glycerin, lidocaine, petrolatum, phenylephrine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84308-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYL GALLATE (UNII: 8D4SNN7V92)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PANTHENOL (UNII: WV9CM0O67Z)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TURMERIC (UNII: 856YO1Z64F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
BROMELAINS (UNII: U182GP2CF3)
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84308-161-02	57 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(84308-161)