Hand Sanitizer by Asiaticon, S.A. de C.V.

Drug Details [pdf]

HAND SANITIZER- alcohol gel
Asiaticon, S.A. de C.V.

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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age
on open skin wounds

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 a 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 a Poison Control Center right away.

Stop use and ask a 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 a Poison Control Center right away.

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.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aloe vera (aloe barbadensis), aminomethylpropanol, glycerin, lavender essence, polyacrylic acid (Carbomer), propylene glycol, tocopherol acetate, water.

Package Label - Principal Display Panel

250 mL NDC: 75192-003-01

Dermx70

Package Label- Principal Display Panel

500 mL NDC: 75192-003-02

Dermx70

Package Label- Principal Display Panel

1000 mL NDC: 75192-003-03

Dermx70

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75192-003
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)	0.002 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.33 mL in 100 mL
WATER (UNII: 059QF0KO0R)	26.448 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1 mL in 100 mL
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)	0.1 mL in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.02 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75192-003-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	08/20/2020
2	NDC: 75192-003-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	08/20/2020
3	NDC: 75192-003-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020	08/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/24/2020	08/20/2020

Labeler - Asiaticon, S.A. de C.V. (951576254)

Registrant - Asiaticon, S.A. de C.V. (951576254)

Name	Address	ID/FEI	Business Operations
Establishment
Asiaticon, S.A. de C.V.		951576254	manufacture(75192-003)

Revised: 8/2020

Document Id: ad5790df-a28a-21f9-e053-2995a90a19b6

Set id: a8ed53fa-06c9-0cb6-e053-2995a90ac8f4

Version: 2

Effective Time: 20200820

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10