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

Careone Citrus Fresh by

Drug Labeling and Warnings

Careone Citrus Fresh 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 CITRUS FRESH- benzalkonium chloride soap 
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), 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).

PDP3

CAREONE CITRUS FRESH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-017
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)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRUS NOBILIS (UNII: 8MFF77J91V)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BASIC YELLOW 5 (UNII: 07BP340B4T)
DIRECT YELLOW 6 (UNII: 9CU9YEE7RC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-017-03	333 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(79147-017)

Revised: 7/2021

Document Id: 0faf4642-b74a-4633-9927-0fee7bdbef8c

34390-5

Set id: cf732122-164e-40b0-bc1a-775e3cf81780

Version: 1

Effective Time: 20210721

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