Aqua Gel by AD MEDIOS, S.A. DE C.V. / AD MEDIOS S.A. DE C.V. AQUA GEL- alcohol gel

Aqua Gel by

Drug Labeling and Warnings

Aqua Gel by is a Otc medication manufactured, distributed, or labeled by AD MEDIOS, S.A. DE C.V., AD MEDIOS S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

20 L NDC:

77739-001-01

20 L NDC: 77739-001-01

3780 mL NDC:

77739-001-02

3780 mL NDC: 77739-001-02

1L NDC:

77739-001-04

1L NDC: 77739-001-04

500 mL NDC:

77739-001-05

500 mL NDC: 77739-001-05

250 mL NDC:

77739-001-06

250 mL NDC: 77739-001-06

5L NDC:

77739-001-12

5L NDC: 77739-001-12

125 mL NDC:

77739-001-08

125 mL NDC: 77739-001-08

60 mL NDC:

77739-001-09

60 mL NDC: 77739-001-09

200L NDC:

77739-001-10

200L NDC: 77739-001-10

1000L 77739-001-11

1000L 77739-001-11

INGREDIENTS AND APPEARANCE

AQUA GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77739-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77739-001-01	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
2	NDC: 77739-001-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
3	NDC: 77739-001-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
4	NDC: 77739-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
5	NDC: 77739-001-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
6	NDC: 77739-001-08	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
7	NDC: 77739-001-09	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
8	NDC: 77739-001-10	200000 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/02/2020
9	NDC: 77739-001-11	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/02/2020
10	NDC: 77739-001-12	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020

Labeler - AD MEDIOS, S.A. DE C.V. (814581377)

Registrant - AD MEDIOS, S.A. DE C.V. (814581377)

Establishment
Name	Address	ID/FEI	Business Operations
AD MEDIOS S.A. DE C.V.		814581377	manufacture(77739-001)