GENTLEHANDS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

GentleHands ANTISEPTIC Hand Sanitizer by

Drug Labeling and Warnings

GentleHands ANTISEPTIC Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ROLDAN INDUSTRIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external us e only

Do not use

in children less than 2 months of age

open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water 

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Keep out of reach of 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
supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30˚C (59-86˚F)
avoid freezing and excessive heat above 40˚C (104˚F)

Inactive ingredients

carbomer, EDTA, glycerol, polysorbate, triethanolamine, water

Questions? +1-786-843-1308

You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

LOT NO. AND EXPIRY

PRINTED ON BOTTLE

Distributed by: Roldan Industries

1500 E Tropicana Ave. Ste 154 Las Vegas NV 89119

COUNTRY OF ORIGIN: MEXICO

Packaging

INGREDIENTS AND APPEARANCE

GENTLEHANDS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79109-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79109-700-22	2 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2020
2	NDC: 79109-700-06	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
3	NDC: 79109-700-11	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
4	NDC: 79109-700-12	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
5	NDC: 79109-700-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
6	NDC: 79109-700-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
7	NDC: 79109-700-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
8	NDC: 79109-700-37	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020

Labeler - ROLDAN INDUSTRIES (117553465)