PDI SANI HANDS- instant hand sanitizing wipes cloth

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Professional Disposables International Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - Antiseptic. - For handwashing to decrease bacteria on the skin. - Recommended for repeated use. - Dries in seconds.
Authorization status:
OTC monograph not final
Authorization number:
10819-3918-1

PDI SANI HANDS- instant hand sanitizing wipes cloth

Professional Disposables International Inc

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.

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Sani-Hands Bedside Pack NDC 10819-3918-1

Active ingredient

Alcohol 70% by volume

Purpos e

Antiseptic

Us es

Antiseptic.

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

Dries in seconds.

Warnings

Flammable, keep away from fire or flame.

For external use only.

Do not use in or contact the eyes.

Discontinue use if irritation and redness develop. If conditions persist for more than 72 hours,

consult a physician.

Keep this out of reach of children

unless under adult supervision.

if swallowed, get medical help or contact a Poison Control Center immediately

Directions

Peel back label slowly.

Pull out wipe and reseal label.

Unfold and use.

Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the

entire wipe surface. Allow to dry.

If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize

with a second wipe.

Discard after single use.

inactive ingredients

Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf juice, Tocopheryl Acetate

Principal Display panel

Reseal lid:

Flowrap:

PDI SANI HANDS

instant hand sanitizing wipes cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 8 19 -39 18

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Professional Disposables International Inc

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 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

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

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:10 8 19 -39 18 -

20 in 1 CELLO PACK

0 4/0 1/20 16

1

4.15 mL in 1 APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

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 4/0 1/20 16

Labeler -

Professional Disposables International Inc (800777117)

Registrant -

Professional Disposables International Inc (800777117)

Revised: 10/2020

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