SANIDRY- hand sanitizer gel gel

Sanidry by

Drug Labeling and Warnings

Sanidry by is a Otc medication manufactured, distributed, or labeled by QUIMICA ROSMAR S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic

Uses

• Hand sanitizing to help reduce bacteria on the skin that potentially can cause disease.
• For use when soap and water are not available

Warnings

​For external use only. Flammable: keep away from fire or flame.

When using this product

​Do not use

• on children less than 2 months.
• on open skin wounds.

Stop use and ask a doctor if

irritation or redness persists for more than 72 hours

Keep out of reach of children unless under adult supervision

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product in your palm to thoroughly cover hands
• Rub hands together briskly until dry
• No rinsing required
• No towels needed

Other information

• Store at temperature below 110 F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

carbomer, glycerin, triethanolamine, purified water USP.

PRINCIPAL DISPLAY PANEL

250 mL - NDC: 77251-003-01

236 mL - NDC: 77251-003-02

500 mL - NDC: 77251-003-03

1000 mL - NDC: 77251-003-04

4000 mL - NDC: 77251-003-05

20 L - NDC: 77251-003-06

200 L- NDC: 77251-003-07

INGREDIENTS AND APPEARANCE

SANIDRY 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77251-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77251-003-01	0.25 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
2	NDC: 77251-003-02	0.236 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
3	NDC: 77251-003-03	0.5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
4	NDC: 77251-003-04	1 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
5	NDC: 77251-003-05	4 L in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020
6	NDC: 77251-003-06	20 L in 1 PAIL; Type 0: Not a Combination Product	06/05/2020
7	NDC: 77251-003-07	200 L in 1 DRUM; Type 0: Not a Combination Product	06/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/05/2020

Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)

Establishment
Name	Address	ID/FEI	Business Operations
QUIMICA ROSMAR S.A. DE C.V.		814223475	manufacture(77251-003)