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

Fresh Water by

Drug Labeling and Warnings

Fresh Water 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]

FRESH WATER- 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

For hand washing to decrease bacteria on the skin.

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 for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply onto dry hands
• Lather and rinse thoroughly with water.

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquatermium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl42090), Ext Violet 2 (Cl 60730)

PDP02

FRESH WATER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-021
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-021-02	222 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(79147-021)

Revised: 7/2021

Document Id: 65d08047-56df-487f-bea2-2e13fee738de

34390-5

Set id: 5afa4d4e-311b-4063-bb80-c84829cfed31

Version: 1

Effective Time: 20210723

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