BLOOP HEMORRHOID RELIEF TOPICAL- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

Bloop Hemorrhoid Relief Topical by

Drug Labeling and Warnings

Bloop Hemorrhoid Relief Topical by is a Otc medication manufactured, distributed, or labeled by Three Nations Corp, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%

PURPOSE

Anorectal (hemorrhoidal)

INDICATIONS & USAGE

• Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful from irritation and abrasion during bowel movement.
• Temporarily shrinks hemorrhoidal tissue.

WARNINGS

For external use only (skin of the perianal area and anal canal).

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
• 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 product into the rectum by using fingers or any mechanical device or applicator

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 immediately.

DOSAGE & ADMINISTRATION

• Gently dry by patting or blotting with toilet tissue or soft cloth before applying
• Carefully apply medication to the perianal skin and anal canal with a clean finger
• Adults and children 12 years and older: apply externally to the affected area up to 4 times daily, especially at night, in morning or after bowel movement
• Children under 12 years of age consult your pediatrician.

INACTIVE INGREDIENT

Benzyl alcohol, carapa guianensis seed oil, cetearyl alcohol, cetyl alcohol, copaifera officinalis (balsam copaiba) resin, disodium EDTA, ethylhexylglycerin, glyceryl stearate SE, mineral oil, propanediol, steareth-21, stearyl alcohol, tocopherol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLOOP HEMORRHOID RELIEF TOPICAL 
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83838-155
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
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE, (+/-)- (UNII: O2VT86KV7E) (PHENYLEPHRINE HYDROCHLORIDE, (+/-)- - UNII:O2VT86KV7E)	PHENYLEPHRINE HYDROCHLORIDE, (+/-)-	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-21 (UNII: 53J3F32P58)
CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83838-155-01	1 in 1 BOX	11/14/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	11/14/2023

Labeler - Three Nations Corp (119050054)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(83838-155)