CAREONE- benzalkonium chloride soap

Careone by

Drug Labeling and Warnings

Careone by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, Apollo Health and Beauty Care, Spa Dent 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), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Yellow 6 (Cl 15985).

PDP03

INGREDIENTS AND APPEARANCE

CAREONE 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BASIC YELLOW 5 (UNII: 07BP340B4T)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRUS NOBILIS (UNII: 8MFF77J91V)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
SODIUM SULFATE (UNII: 0YPR65R21J)
DIRECT YELLOW 6 (UNII: 9CU9YEE7RC)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-003-03	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/26/2021

Labeler - Retail Business Services, LLC (967989935)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Spa Dent Inc		203478896	manufacture(72476-003)