CAREONE AMBER ANTIBACTERIAL HAND- benzalkonium chloride soap

CareOne Amber Antibacterial Hand by

Drug Labeling and Warnings

CareOne Amber Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacteria on hands. 

Warnings

For external use only.

When using this product

• avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• apply onto wet hands.
• lather and rinse thoroughly.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Label Copy

INGREDIENTS AND APPEARANCE

CAREONE AMBER ANTIBACTERIAL HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-320-11	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/18/2019

Labeler - American Sales Company (809183973)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(41520-320)