AQUA 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

polyacrylic acid (Carbomer), triethanolamine (Trolamine), water

20 L NDC: 77739-001-01

20 L NDC: 77739-001-01 AQUAGEL_01

3780 mL NDC: 77739-001-02

AQUAGEL_023780 mL NDC: 77739-001-02

1L NDC: 77739-001-04

AQUAGEL_041L NDC: 77739-001-04

500 mL NDC: 77739-001-05

AQUAGEL_05500 mL NDC: 77739-001-05

250 mL NDC: 77739-001-06

AQUAGEL_06250 mL NDC: 77739-001-06

5L NDC: 77739-001-12

5L NDC: 77739-001-12

AQUAGEL_07P

125 mL NDC: 77739-001-08

AQUAGEL_08125 mL NDC: 77739-001-08

60 mL NDC: 77739-001-09

AQUAGEL_0960 mL NDC: 77739-001-09

200L NDC: 77739-001-10

SAQUAGEL_10200L NDC: 77739-001-10

1000L 77739-001-11

1000L 77739-001-11 AQUAGEL_11

AQUA GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77739-001
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) 0.03 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.97 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77739-001-0120000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
2NDC:77739-001-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
3NDC:77739-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
4NDC:77739-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
5NDC:77739-001-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
6NDC:77739-001-08125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
7NDC:77739-001-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
8NDC:77739-001-10200000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
9NDC:77739-001-111000000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
10NDC:77739-001-125000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/28/2021
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(77739-001)

Revised: 1/2021
Document Id: b9cf6c77-85dc-62d9-e053-2995a90abe32
Set id: a619da09-69ea-4679-e053-2a95a90a9487
Version: 3
Effective Time: 20210126
 
AD MEDIOS, S.A. DE C.V.