Careone Amber by Spa Dent Inc / Apollo Health and Beauty Care Drug Facts

Careone Amber by

Drug Labeling and Warnings

Careone Amber by is a Otc medication manufactured, distributed, or labeled by Spa Dent Inc, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAREONE AMBER- benzalkonium chloride solution 
Spa Dent Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

PDP2

PDP3

PDP4

CAREONE AMBER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-018
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
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)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
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)
BASIC YELLOW 5 (UNII: 07BP340B4T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-018-02	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/2021
2	NDC: 79147-018-03	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/2021
3	NDC: 79147-018-04	1660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2021

Labeler - Spa Dent Inc (203478896)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Spa Dent Inc		203478896	manufacture(79147-018)

Revised: 7/2021

Document Id: 188b0ab9-76b9-4d1f-a476-ca04fe2c5eaa

34390-5

Set id: 0dcceba3-2685-4fa0-a3b5-50e7f7fb029e

Version: 1

Effective Time: 20210722

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