REFILL 6- alcohol, water kit

Refill 6 by

Drug Labeling and Warnings

Refill 6 by is a Otc medication manufactured, distributed, or labeled by CMC Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts - Hand Sanitizer

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin

• Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame
For external use only.

Do not use

• in the eyes.

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Keep out of reach children.

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

Directions

• Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Drug Facts - Eye Wash

Active ingredient

Purified Water 99.1%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface do not reuse once opened, discard obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

you experience: eye pain changes in vision continued redness irritation of the eye condition worsens or persists

Keep out of reach of children.

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

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

not for use as contact lens solution

use before expiration date marked on the bottle

store at room temperature, 5° to 35°C (41° to 95°F)

Inactive ingredients

Benzalkonium chloride, sodium chloride

Hand Sanitizer (

49687-0015-0) Labeling:

Eye Wash (50814-010-01) Labeling:

Refill 6 (

49687-0019-0) Labeling:

INGREDIENTS AND APPEARANCE

REFILL 6 
alcohol, water kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49687-0019

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49687-0019-0	1 in 1 KIT	08/10/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 BOTTLE	5.4 g
Part 2	1 TUBE	30 mL

Part 1 of 2

HAND SANITIZER 
alcohol gel

Product Information
Item Code (Source)	NDC: 49687-0015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49687-0015-0	6 in 1 KIT
1		0.9 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/10/2016

Part 2 of 2

EYE WASH 
water solution

Product Information
Item Code (Source)	NDC: 49687-0010
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	991 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49687-0010-1	1 in 1 BOX
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	08/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/10/2016

Labeler - CMC Group, Inc. (005583328)