Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand rub to help reduce bacteria that potentially can cause disease when water is 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.

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

Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine

Questions or Comments

PGH Laboratorios do Brasil Ltda.

SAC (931) 444-6323

sac@dermonano.com.br

Principal Display Panel

NDC: 75751-070-04

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Net Wt. 120g e 4.2 oz

Label

NDC: 75751-070-16

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 480g e 16.9 oz

Label 1

NDC: 75751-070-26

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 1000L e 33814oz

Label 2

DERMONANO
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75751-070
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PANTHENOL (UNII: WV9CM0O67Z)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75751-070-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
2	NDC:75751-070-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
3	NDC:75751-070-26	1000000 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/11/2020

Labeler - PGH LABORATORIOS DO BRASIL LTDA. (903309948)

Registrant - PGH LABORATORIOS DO BRASIL LTDA. (903309948)