CAREONE AMBER- benzalkonium chloride soap

Careone Amber by

Drug Labeling and Warnings

Careone Amber by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, Apollo Health and Beauty Care. 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 Poison Control Center immediately.

Directions

• apply onto wet hands (only for 222 ml and 333 ml)
• Lather and rinse thoroughly.(For all packages)
• From a pump bottle, apply onto wet hands (only for 1.66 L bottle)
• Use to refill a pump bottle (only for 1.66 L bottle)

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 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions or comments?

1-877-846-9949

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INGREDIENTS AND APPEARANCE

CAREONE AMBER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-004
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
COCO MONOETHANOLAMIDE (UNII: C80684146D)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
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: 72476-004-02	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2021
2	NDC: 72476-004-03	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2021
3	NDC: 72476-004-04	1660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2021

Labeler - Retail Business Services, LLC (967989935)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(72476-004)