SAFEHANDS FRAGRANCE FREE- benzalkonium chloride liquid

safeHands by

Drug Labeling and Warnings

safeHands by is a Otc medication manufactured, distributed, or labeled by Alden Medical LLC, SafeHands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Liberally apply to skin by gently massaging until absorbed.

Warnings

For external use only. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and aska doctor if skin irritation develops.

Inactive Ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Propylene glycol,Triethylene glycol, Polysorbate-20.

Uses

To decrease bacteria on the skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Purpose

Antiseptic Hand Sanitizer

Active Ingredient

Benzalkonium chloride 0.13%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFEHANDS  FRAGRANCE FREE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72646-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72646-101-02	52 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/27/2014
2	NDC: 72646-101-07	208 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/27/2014
3	NDC: 72646-101-18	532 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/27/2014
4	NDC: 72646-101-99	208 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/27/2014

Labeler - Alden Medical LLC (618196968)

Registrant - SafeHands (618196968)

Establishment
Name	Address	ID/FEI	Business Operations
Alden Medical LLC		618196968	manufacture(72646-101) , analysis(72646-101)