MEDSHIELD PRODUCTS- hand sanitizer gel gel

MedShield Products by

Drug Labeling and Warnings

MedShield Products by is a Otc medication manufactured, distributed, or labeled by HWL Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.1% Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that could cause disease

Warnings

For external use only-hands

WHEN USING

keep out of eyes In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Rub thoroughly over all surfaces of both hands.
• Rub hands together briskly until dry.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aloe oil, *carbomer, *carbopol aqua SF-1, glycerol, *hydroxyethyl cellulose, *hydroxypropyl methyl cellulose, sodium hydroxide, water

*contains one or more of these ingredients

Package Label - Principal Display Panel

236 mL NDC: 75446-222-17

INGREDIENTS AND APPEARANCE

MEDSHIELD PRODUCTS 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75446-222
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75446-222-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
2	NDC: 75446-222-05	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
3	NDC: 75446-222-07	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
4	NDC: 75446-222-09	75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
5	NDC: 75446-222-11	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
6	NDC: 75446-222-13	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
7	NDC: 75446-222-15	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
8	NDC: 75446-222-17	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
9	NDC: 75446-222-19	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
10	NDC: 75446-222-21	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
11	NDC: 75446-222-23	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
12	NDC: 75446-222-25	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
13	NDC: 75446-222-27	1183 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
14	NDC: 75446-222-29	1892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
15	NDC: 75446-222-31	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
16	NDC: 75446-222-33	10000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
17	NDC: 75446-222-35	12000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - HWL Holdings, LLC (058630887)

Establishment
Name	Address	ID/FEI	Business Operations
HWL Holdings, LLC		058630887	manufacture(75446-222)