Hypercln by Falcon Safety Products, Inc. / Dan Mor Hypercln

Hypercln by

Drug Labeling and Warnings

Hypercln by is a Otc medication manufactured, distributed, or labeled by Falcon Safety Products, Inc., Dan Mor. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYPERCLN- anti-microbial cloth 
Falcon Safety Products, 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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Hypercln

Active Ingredient

Benzalkonium chloride 0.1%

Purpose

Anti-bacterial

Keep out of the reach of children.

Keep out of reach of children, except with adult supervision.

Warnings

For external use only. Do not use in the eyes.

Keep out of eyes. In case of eye contact, rinse with water. If irritation develops, discontinue use. Consult doctor if irritation persists for more than 72 hours.

If swallowed, seek medical attention or contact a Poison Control Center.

Inactive Ingredients

Aqua, Decyl Glucoside, Glycerin, Sodium Hydroxymethylglycinate, Citric Acid, PEG-12 Dimethicone Copolyol, Tetrasodium EDTA, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Allantoin, Panthenol, Tocopheryl Acetate, Fragrance

Directions

1. Tear open and unfold wipe 2. Sanitize hands and affected area. 3. Discard in trash after use. Do not flush.

Use

1. Tear open and unfold wipe. 2. Sanitize hands and affected area. 3. Discard in trash after use. Do not flush.

Label

HYPERCLN 
anti-microbial cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78847-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
CHAMOMILE (UNII: FGL3685T2X)
EDETATE SODIUM (UNII: MP1J8420LU)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78847-222-01	1 in 1 PACKET; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	07/15/2020

Labeler - Falcon Safety Products, Inc. (150582500)

Registrant - Dan Mor (514523067)

Establishment
Name	Address	ID/FEI	Business Operations
Dan Mor		514523067	manufacture(78847-222)

Revised: 7/2020

Document Id: aa7c5e04-3180-4477-e053-2995a90a66c9

34390-5

Set id: a7eb256c-24ef-20e7-e053-2a95a90aecfa

Version: 2

Effective Time: 20200715