SANNYTIZE HAND SANITIZER- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Dynarex Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
An antiseptic handwash. Cleaning and antiseptic cleansing of hands and skin.
Authorization status:
OTC monograph not final
Authorization number:
67777-317-01, 67777-317-02, 67777-317-03, 67777-317-04, 67777-317-05, 67777-317-06, 67777-317-07

SANNYTIZE HAND SANITIZER- alcohol gel

Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

1427 Dynarex SannyTize Hand Sanitizer NDC 67777-317-01

1428 Dynarex SannyTize Hand Sanitizer NDC 67777-317-02

1429 Dynarex SannyTize Hand Sanitizer NDC 67777-317-03

1431 Dynarex SannyTize Hand Sanitizer NDC 67777-317-04

1432 Dynarex SannyTize Hand Sanitizer NDC 67777-317-05

1433 Dynarex SannyTize Hand Sanitizer NDC 67777-317-06

ACTIVE INGREDIENT

Active Ingredient Purpose

Ethyl Alcohol 0.62% Antiseptic Handwash

WARNINGS

For external use only

Flammable, keep away from fire and flame

Do not use

in or near the eyes

When using this product avoid contact with eyes. In case of eye contact, rinse with water to

remove.

Stop use and ask a doctor if irritation and redness develops

PURPOSE

An antiseptic handwash.

INDICATIONS & USAGE

Cleaning and antiseptic cleansing of hands and skin.

DOSAGE & ADMINISTRATION

Wet hands thoroughly with product and allow to dry without wiping

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.

INACTIVE INGREDIENTS

Inactive ingredients: Water, Glycerin, Propylene glycol, Carbomer, Triethanolamine, Aloe barbadensis

juice, Fragrance

PRINCIPAL DISPLAY PANEL

Dynarex SannyTize Hand Sanitizer

hand sanitizer.jpg

SANNYTIZE HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7777-317

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .6 2 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Dynarex Corporation

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 7777-317-

29 .5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

2

NDC:6 7777-317-

59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

3

NDC:6 7777-317-

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

4

NDC:6 7777-317-

236 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

5

NDC:6 7777-317-

473 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/25/20 17

6

NDC:6 7777-317-

1.0 35 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

7

NDC:6 7777-317-

1.0 35 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 4/25/20 17

Labeler -

Dynarex Corporation (008124539)

Registrant -

Dynarex Corporation (008124539)

Revised: 3/2019

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