ALCOHOL WET WIPES- alcohol cloth

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Disponível em:

Robert Gordon Ind. Ltd.

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

- For hand sanitizing to decrease bacteria on the skin

Status de autorização:

OTC monograph not final

Características técnicas

ALCOHOL WET WIPES- ALCOHOL CLOTH
ROBERT GORDON IND. LTD.
_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._
----------
ALCOHOL WET WIPES
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol 75% (v/v)
_PURPOSE_
Antiseptic
_USES_
For hand sanitizing to decrease bacteria on the skin
_WARNINGS_
Flammable. Keep away from heat and flame.
For External use only.
DO NOT USE
In eyes. In case of contact, rinse thoroughly with water
_WHEN USING THIS PRODUCT_
avoid contact with eyes and mouth. If in ayes, flush thoroughly with
water.
Discontinue use and contact a doctor if irritation and redness develop
and conditions
persis 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_
Tear open packet and remove wipe.
Wet hands thoroughly with product and let hands air dry.
Throw used wipe in trash. Do not flush.
_INACTIVE INGREDIENT_
Water
_OTHER INFORMATION_
Store between 15-30
C (59-86
F)
Avoid freezing and excessive heat above 40
C (104
F)
PACKAGE LABELING:10COUNT
o
o
o
o
PACKAGE LABELING:40COUNT
PACKAGE LABELING:80COUNT
ALCOHOL WET WIPES
alcohol cloth
PRODUCT INFORMATION
Robert Gordon Ind. Ltd.
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:74979-006
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.75 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:74979-
006-01
10 in 1 PACKAGE
08/20/2020
1
4.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
2
NDC:74979-
006-02
40 in 1 PACKAGE
08/20/2020
04/15/2023
2
4.75 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe,