BLOOP FISSURE HEALING ANORECTAL TOPICAL- lidocaine cream

Bloop Fissure Healing Anorectal Topical by

Drug Labeling and Warnings

Bloop Fissure Healing Anorectal 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

Lidocaine 5%

PURPOSE

Anorectal (hemorrhoidal)

INDICATIONS & USAGE

• Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders

WARNINGS

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

When using this product

• 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

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• rectal bleeding occurs
• 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

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 6 times a day
• Children under 12 years of age consult a doctor

INACTIVE INGREDIENT

Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLOOP FISSURE HEALING ANORECTAL TOPICAL 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83838-153
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
CARBOMER 940 (UNII: 4Q93RCW27E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ACAI OIL (UNII: Z0W6766A2W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PENTACLETHRA MACROLOBA SEED OIL (UNII: OM0BAV5397)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83838-153-01	1 in 1 CARTON	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(83838-153)