Dead Sea Collection Antibacterial Hand Spiced Apple

Dead Sea Collection Antibacterial Hand Spiced Apple by

Drug Labeling and Warnings

Dead Sea Collection Antibacterial Hand Spiced Apple by is a Otc medication manufactured, distributed, or labeled by CrystalLine Health & Beauty from the Dead Sea LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEAD SEA COLLECTION ANTIBACTERIAL HAND SPICED APPLE- benzalkonium chloride liquid 
CrystalLine Health & Beauty from the Dead Sea LTD

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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Dead Sea Collection Antibacterial Hand Spiced Apple

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

Helps eliminate bacteria on hands.

Warnings

For external use only.

When using this product

Avoid contact with eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor

if irritation or redness persists.

Keep out of reach of children.

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

Directions

Use whenever washing your hands. Rinse with warm water.

Inactive ingredients:

Water/Aqua, Sodium Laureth Sulphate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Maris Sal (Dead Sea Minerals), Pyrus Malus (Apple), DMDM, Hydantoin, Triethylene Glycol, Propylene Glycol, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Nitrate, Magnesium Chloride, Tetrasodium EDTA, Citric Acid.

Package Labeling:

DEAD SEA COLLECTION ANTIBACTERIAL HAND SPICED APPLE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71095-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
APPLE (UNII: B423VGH5S9)
HYDANTOIN (UNII: I6208298TA)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71095-014-00	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020	12/31/2022

Labeler - CrystalLine Health & Beauty from the Dead Sea LTD (600582704)

Revised: 6/2022

Document Id: e06938eb-392b-6b11-e053-2a95a90aadf4

34390-5

Set id: ae57e20a-57f1-1c81-e053-2995a90a985f

Version: 2

Effective Time: 20220601

 

CrystalLine H