ACCURATE LABS ANTISEPTIC HAND SANITIZER

ACCURATE LABS ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

ACCURATE LABS ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Accurate Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACCURATE LABS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
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

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

Inactive ingredients

Carbopol Aqua SF-1, d-limonene, glycerin,triethanolamine, 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

ACCURATE LABS ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78434-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78434-100-02	0.059 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2025
2	NDC: 78434-100-04	0.118 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2025
3	NDC: 78434-100-08	0.236 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2025
4	NDC: 78434-100-16	0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2025
5	NDC: 78434-100-32	0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2025
6	NDC: 78434-100-64	1.89 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025
7	NDC: 78434-100-70	3.79 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025
8	NDC: 78434-100-75	9.46 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025
9	NDC: 78434-100-80	18.93 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025
10	NDC: 78434-100-85	208.2 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025
11	NDC: 78434-100-90	1211.33 L in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	06/30/2025

Labeler - Accurate Labs, LLC (113427259)

Establishment
Name	Address	ID/FEI	Business Operations
Accurate Labs, LLC		113427259	manufacture(78434-100)

Revised: 10/2021

Document Id: 576df427-f9eb-4f3f-a5d0-ee443a6ea797

34390-5

Set id: 4f337431-5c0e-419f-8377-846454811610

Version: 2

Effective Time: 20211007