GP ENMOTION ANTIMICROBIAL FOAM- benzalkonium chloride solution

GP enMotion Antimicrobial Foam by

Drug Labeling and Warnings

GP enMotion Antimicrobial Foam by is a Otc medication manufactured, distributed, or labeled by Georgia-Pacific Consumer Products, CYAN Labs S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Use

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

For external use only

When using this product

Avoid contact with eyes. In case of eye contact, flush with water.

Stop use

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a poison control center.

Directions

Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly.

Inactive ingredients

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Euterpe Oleracea Fruit Extract, Oleth-10, Tetrasodium EDTA, Citric Acid, Green 5, Yellow 10, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GP ENMOTION ANTIMICROBIAL FOAM 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54622-312
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OAT (UNII: Z6J799EAJK)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
OLETH-10 (UNII: JD797EF70J)
WATER (UNII: 059QF0KO0R)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE SODIUM (UNII: MP1J8420LU)
ACAI (UNII: 46AM2VJ0AW)
LAURYL BETAINE (UNII: Y4P927Q133)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54622-312-01	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/29/2021

Labeler - Georgia-Pacific Consumer Products (806142217)

Registrant - Cyan Labs S.A. de C.V. (812754130)

Establishment
Name	Address	ID/FEI	Business Operations
Cyan Labs S.A. de C.V.		812754130	manufacture(54622-312) , analysis(54622-312) , label(54622-312) , pack(54622-312)