ALOE FORMULA ANTIBACTERIAL- benzalkonium chloride soap

Aloe Formula by

Drug Labeling and Warnings

Aloe Formula by is a Otc medication manufactured, distributed, or labeled by BBC Group Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin.

Warnings

For external use only

When using this product

■ do not get into eyes.

■ if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

■ irritation and redness develops

Keep out of reach of children

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

Directions

■ Squeeze into hands and lather with water. Rinse well

Inactive ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glyceryl Laurate, Phenoxyethanol, Fragrance, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Disodium EDTA, Citric Acid, Magnesium Chloride, Methylchloroisothiazolinone, Magnesium Nitrate, Methylisothiazolinone

Package Label

INGREDIENTS AND APPEARANCE

ALOE FORMULA  ANTIBACTERIAL
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76383-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
GLYCERYL LAURATE (UNII: Y98611C087)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76383-019-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - BBC Group Ltd (421270060)

Establishment
Name	Address	ID/FEI	Business Operations
BBC Group Ltd		421270060	manufacture(76383-019)