DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF- benzocaine, benzalkonium chloride cream

DEBACHERE Butt Balm After Care Antiseptic Pain Relief by

Drug Labeling and Warnings

DEBACHERE Butt Balm After Care Antiseptic Pain Relief by is a Otc medication manufactured, distributed, or labeled by DE.BACHERE USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzocaine 5.00%

Benzalkonium Chloride 0.10%

Purpose

Topical Analgesic

Antiseptic

Uses:

• For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
• First aid help prevent infection in minor cuts, scrapes, and burns.

Warnings:

For external use only,not intended for ingestion.

Do not use

• in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

When using this product

• avoid contact with the eyes.

Stop use and ask a doctor if

• The condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions

• Clean the affected area.
• Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily.
• Children under 2 years of age: Consult a doctor.

Other information:

Store at 20-25°C (60-77°F) and protect from moisture.

Inactive Ingridients:

Aloe extract, Beeswax, Camphor, Cetyl Esters, Ethyl vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Salicylic Acid, Theobroma Cacao (cocoa) butter, FD&C Blue # 1.

Package Labeling:

INGREDIENTS AND APPEARANCE

DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF 
benzocaine, benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84847-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	50 mg  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
YELLOW WAX (UNII: 2ZA36H0S2V)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ETHYL VANILLIN (UNII: YC9ST449YJ)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LANOLIN (UNII: 7EV65EAW6H)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PARAFFIN (UNII: I9O0E3H2ZE)
SALICYLIC ACID (UNII: O414PZ4LPZ)
COCOA (UNII: D9108TZ9KG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84847-540-00	3 mL in 1 PACKET; Type 0: Not a Combination Product	09/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/27/2024

Labeler - DE.BACHERE USA LLC (127815393)