PACIFIC GEL- alcohol gel

Pacific Gel by

Drug Labeling and Warnings

Pacific Gel by is a Otc medication manufactured, distributed, or labeled by Ad Medios & Mkt, 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

PRINCIPAL DISPLAY PANEL

60 ML NDC: 79058-002-01

PRINCIPAL DISPLAY PANEL

250 ML NDC: 79058-002-02

PRINCIPAL DISPLAY PANEL

500 ML NDC: 79058-002-03

PRINCIPAL DISPLAY PANEL

1000 ML NDC: 79058-002-04

PRINCIPAL DISPLAY PANEL

3785 ML NDC: 79058-002-05

PRINCIPAL DISPLAY PANEL

20L NDC: 79058-002-07

PRINCIPAL DISPLAY PANEL

200,000 ml NDC: 79058-002-08

PRINCIPAL DISPLAY PANEL

5000 ml NDC: 79058-002-06

INGREDIENTS AND APPEARANCE

PACIFIC GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79058-002
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
TROLAMINE (UNII: 9O3K93S3TK)	1 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.03 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: 79058-002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
2	NDC: 79058-002-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
3	NDC: 79058-002-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
4	NDC: 79058-002-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
5	NDC: 79058-002-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
6	NDC: 79058-002-06	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
7	NDC: 79058-002-07	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
8	NDC: 79058-002-08	200000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/18/2020

Labeler - Ad Medios & Mkt, S.A. de C.V. (812886810)

Registrant - Ad Medios & Mkt, S.A. de C.V. (812886810)

Establishment
Name	Address	ID/FEI	Business Operations
Ad Medios & Mkt, S.A. de C.V.		812886810	manufacture(79058-002) , label(79058-002)