ALCOHOL PREP- isopropyl alcohol swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

KYJ Medical Products Co.,Ltd.

INN (International Name):

ISOPROPYL ALCOHOL

Composition:

ISOPROPYL ALCOHOL 0.7 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Use for preparation of the skin prior to an injection

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL PREP- ISOPROPYL ALCOHOL SWAB
KYJ MEDICAL PRODUCTS CO.,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._
----------
KYJ MEDICAL ALCOHOL PREP PAD MEDIUM STERILE ,SINGLE USE, LATEX-FREE
SATURATED WITH 70% V/V
ISOPROPYL ALCOHOL
ACTIVE INGREDIENT
Isopropyl Alcohol 70%
PURPOS E
Antiseptic
US E
Use for preparation of the skin prior to an injection
WARNNING
For External use only.
Flammable,keep away from fire or flame.
Do not use with electrocautery procedures in eyes.
Stop use and ask a doctor if irritation and redness develop,condition
persists for more than 72 hours .
Keep out of reach of children in case of accidental ingestion,seek
professional assistance or consult a
Poison Control Center immediately.
DIRECTIONS
Apply alcohol as needed to clean intended area. Discard after single
use.
INACTIVE INGREDIENTS
Inactive Ingredients: Purified Water
Keep out of reach of children in case of accidental ingestion,seek
professional assistance or consult a
Poison Control Center immediately.
ALCOHOL PREP
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 16 1-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -
UNII:ND2M416 30 2)
ISOPROPYL ALCOHOL
0 .7 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
0 .3 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 16 1-0 0 1-0 1
1 in 1 PACKAGE
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 4/20 /20 11
KYJ Medical Products Co.,Ltd.
LABELER -
KYJ Medical Products Co.,Ltd. (421270350)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
KYJ Medical Pro d