SPECTRUM HAND SANITIZER WIPES- ethyl alcohol cloth

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Medline Industries, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - to decrease bacteria on the skin that could cause disease
Authorization status:
OTC monograph not final
Authorization number:
53329-840-29, 53329-840-32, 53329-840-63

SPECTRUM HAND SANITIZER WIPES- ethyl alcohol cloth

Medline Industries, 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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Spectrum Hand Sanitizer Wipes

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease

Warnings

For external use only: hands

Flammable. Keep away from fire and flame.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

do not inhale or ingest

Stop Use and ask a doctor if

irritation or redness develops

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

wet hands thoroughly with product and allow to dry without wiping

not recommended for infants

Other information

do not store above 105ºF

may discolor some fabrics

harmful to wood finishes and plastics

Inactive Ingredients

aloe barbadensis leaf juice, glycerin, isopropanol, propanediol, tocopheryl acetate, water

Packaging Label

SPECTRUM HAND SANITIZER WIPES

ethyl alcohol cloth

Product Information

Medline Industries, Inc.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53329 -8 40

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

70 mL

Inactive Ingredients

Ingredient Name

Stre ng th

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

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

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53329 -8 40 -32

20 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

2

NDC:53329 -8 40 -29

50 in 1 CANISTER; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

3

NDC:53329 -8 40 -6 3

16 0 in 1 CANISTER; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

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 1/0 1/20 19

Labeler -

Medline Industries, Inc. (025460908)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Guy & O'Neill, Inc.

9 26 8 30 56 3

ma nufa c ture (53329 -8 40 )

Revised: 12/2019

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