GENTLEHANDS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
ROLDAN INDUSTRIES

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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GentleHands ANTISEPTIC Hand Sanitizer

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

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

untitled

GENTLEHANDS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79109-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79109-700-222 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2020
2NDC:79109-700-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
3NDC:79109-700-11120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
4NDC:79109-700-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
5NDC:79109-700-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
6NDC:79109-700-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
7NDC:79109-700-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
8NDC:79109-700-373785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2020
Labeler - ROLDAN INDUSTRIES (117553465)

Revised: 8/2020
Document Id: 6e8b638a-364d-4586-952f-a7decd050700
Set id: 95d86f89-f57e-4614-8dca-2460b617fe97
Version: 1
Effective Time: 20200810
 
ROLDAN INDUSTRIES