ACCURATE LABS ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid 
Accurate Labs, LLC

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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ACCURATE LABS ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Uses

• 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 use only

Do not use • in children less than 2 months of age • on 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

Other information

• store between 20-25°C (68-77°F)
• avoid freezing and excessive heat above 40°C (104°F)
• may discolor certain fabrics

Inactive ingredients

d-limonene, glycerin, water

Questions?

1-800-484-1699

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

Alcohol Antiseptic 80%

Topical Solution

Non-Sterile Solution

Manufactured for: Accurate Labs, LLC
301W 50th St, Odessa, TX 79764

Packaging

untitled

ACCURATE LABS ANTISEPTIC HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78434-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78434-110-020.059 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
2NDC:78434-110-040.118 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
3NDC:78434-110-080.236 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
4NDC:78434-110-160.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
5NDC:78434-110-320.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202006/30/2025
6NDC:78434-110-641.89 L in 1 BOTTLE; Type 0: Not a Combination Product06/01/202006/30/2025
7NDC:78434-110-703.79 L in 1 BOTTLE; Type 0: Not a Combination Product06/01/202006/30/2025
8NDC:78434-110-759.46 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
9NDC:78434-110-8018.93 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
10NDC:78434-110-85208.2 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
11NDC:78434-110-901211.3 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/202006/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/202006/30/2025
Labeler - Accurate Labs, LLC (113427259)
Establishment
NameAddressID/FEIBusiness Operations
Accurate Labs, LLC113427259manufacture(78434-110)

Revised: 10/2021
Document Id: 6d26614f-a7d8-42ad-acce-039dd56f0fa0
Set id: 2946e132-67d4-4558-8865-aad178913b94
Version: 2
Effective Time: 20211007
 
Accurate Labs, LLC