Alvaseptic by Alvachem LLC Hand Saniter Gel

Alvaseptic by

Drug Labeling and Warnings

Alvaseptic by is a Otc medication manufactured, distributed, or labeled by Alvachem LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALVASEPTIC- alcohol hand sanitizer gel gel 
Alvachem LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hand Saniter Gel

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings

For external use only. Flammable. Keep away from heat and flame.

Inactive Ingredients

Purified water USP, Carbomer L, Triethanolamine, Diethanolamine, Monoethanolamine, Monoproplylene Glycol

When Using:

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

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

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.

Purpose

Antiseptic, Hand Sanitizer

Active Ingredient

Alcohol 73% V/V

1 gallon hand sanitizer gel

ALVASEPTIC 
alcohol hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77312-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	610.28 g  in 836 g

Inactive Ingredients
Ingredient Name	Strength
DIETHANOLAMINE (UNII: AZE05TDV2V)	0.96976 g  in 836 g
TROLAMINE (UNII: 9O3K93S3TK)	58.52 g  in 836 g
MONOETHANOLAMINE (UNII: 5KV86114PT)	0.03344 g  in 836 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	25.08 g  in 836 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	58.52 g  in 836 g
WATER (UNII: 059QF0KO0R)	135.432 g  in 836 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77312-011-15	836 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/17/2020	06/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/15/2020	07/15/2021

Labeler - Alvachem LLC (797158719)

Establishment
Name	Address	ID/FEI	Business Operations
Alvachem LLC		797158719	manufacture(77312-011)

Revised: 7/2020

Document Id: a7a917b1-a8c1-67ff-e053-2a95a90a4382

34390-5

Set id: a7a917b1-a8c0-67ff-e053-2a95a90a4382

Version: 1

Effective Time: 20200715

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