AD GEL- alcohol gel 
AD MEDIOS, 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

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

Other information

Inactive ingredients

glycerin, polyacrylic acid (Carbomer), triethanolamine (trolamine), Water.

Package Label - Principal Display Panel

500 mL NDC: 77739-002-01

AD GEL

1000 mL NDC: 77739-002-02

AD GEL

3785 mL NDC: 77739-002-03

AD GEL

20000 mL NDC: 77739-002-04

AD GEL

200000 mL NDC: 77739-002-05

AD GEL

60 ML60 mL NDC: 77739-002-07

250 ML250 mL NDC: 77739-002-06

AD GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77739-002
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
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) 0.35 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.9 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77739-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
2NDC:77739-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
3NDC:77739-002-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
4NDC:77739-002-0420000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
5NDC:77739-002-05200000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
6NDC:77739-002-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
7NDC:77739-002-0760 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2020
Labeler - AD MEDIOS, S.A. de C.V. (814581377)
Registrant - AD MEDIOS, S.A. de C.V. (814581377)
Establishment
NameAddressID/FEIBusiness Operations
AD MEDIOS, S.A. de C.V.814581377manufacture(77739-002)

Revised: 12/2020
Document Id: b5fbef0e-c35e-4fe8-e053-2a95a90a7e54
Set id: a7229975-33ef-c879-e053-2995a90a1854
Version: 5
Effective Time: 20201208
 
AD MEDIOS, S.A. de C.V.