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NDC 00295-9049-23 Stay Safe Hand Sanitizer Alcohol Free 0.13 mg/100mL Details

Stay Safe Hand Sanitizer Alcohol Free 0.13 mg/100mL

Stay Safe Hand Sanitizer Alcohol Free is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Denison Pharmaceuticals, LLC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00295-9049
Product ID	0295-9049_a44b9fb7-87e4-2185-e053-2a95a90a5b6e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stay Safe Hand Sanitizer Alcohol Free
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	mg/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Denison Pharmaceuticals, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00295-9049-23 (00295904923)

Pricing Information	N/A
NDC Package Code	0295-9049-23
Billing NDC	00295904923
Package	177.441 mL in 1 BOTTLE (0295-9049-23)
Marketing Start Date	2020-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a44b9fb7-87e3-2185-e053-2a95a90a5b6e Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses:

For hand sanitizing to decrease bacteria and viruses on the skin
Recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of contact flush eyes with water.

Stop use or ask a doctor if irritation or redness develops or if condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Pump a small amount of liquid into palm of hand • Rub thoroughly over all surfaces on both hands for 15 seconds • Rinse with potable water (Optional)

Other Information

Avoid excessive heat

Inactive Ingredients

Purified water, Aloe Vera Gel 10:1 Concentrate, Edetate Disodium Dihydrate USP, Igepal CO-630, Propylene Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STAY SAFE HAND SANITIZER ALCOHOL FREE

benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0295-9049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0295-9049-23	177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020

Labeler - Denison Pharmaceuticals, LLC (001207208)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9049)

Revised: 4/2020

Document Id: a44b9fb7-87e4-2185-e053-2a95a90a5b6e

Set id: a44b9fb7-87e3-2185-e053-2a95a90a5b6e

Version: 1

Effective Time: 20200427