HOME FORMATION ANTIBACTERIAL SHEA BUTTER- benzalkonium chloride liquid

HOME FORMATION ANTIBACTERIAL SHEA BUTTER by

Drug Labeling and Warnings

HOME FORMATION ANTIBACTERIAL SHEA BUTTER by is a Otc medication manufactured, distributed, or labeled by PATCOS COSMETICS (INDIA) PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Warnings

For external use only.
When using this product avoid contact with eyes . In case of eyes contact, flush 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.

Uses

For hand washing to decrease bacteria on the skin.

Directions

Pump into hands.
Lather vigorously for at least 15 seconds.
Rinse and dry thoroughly.

KEEP OUT OF REACH OF CHILDREN

Inactive ingredient

Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,
Cocomonoethanolamide, Sodium Chloride, Glycerine,Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA,Phenoxyethanol, Benzophenone 3, Citric Acid, CI. No. 17200,  FD and C Yellow 5,CI. No. 19140 , D and C Red 33.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOME FORMATION ANTIBACTERIAL SHEA BUTTER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68121-005
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
BRONOPOL (UNII: 6PU1E16C9W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOPHENONE (UNII: 701M4TTV9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
LAURETH-10 (UNII: BD7AST04GA)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68121-005-01	333 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/03/2021

Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451)