ALCOHOL CLEANSING- 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:

GFA Production (Xiamen) Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For preparation of the skin before injection.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL CLEANSING- ISOPROPYL ALCOHOL SWAB
GFA PRODUCTION (XIAMEN) 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._
----------
ALCOHOL CLEANSING PAD
DRUG FACTS
ACTIVE INGREDIENT:
Isopropyl Alcohol, 70% v/v
PURPOS E
Antiseptic
US E:
For preparation of the skin before injection.
WARNINGS :
FOR EXTERNAL USE ONLY.
FLAMMABLE
keep away from fire or flame.
DO NOT USE:
with electrocautery, in the eyes
STOP USE
if irritation and redness develop. if condition persists for more than
72 hours, consult your doctor.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS :
Wipe injection site vigorously and discard.
OTHER INFORMATION
Store at room temperature 15°-30° C (59°-86° F)
INACTIVE INGREDIENT:
Purified water.
PACKAGE LABELING:
ALCOHOL CLEANSING
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 8 14-0 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 70 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:50 8 14-
0 0 1-0 1
1 in 1 BOX
0 3/22/20 16
1
0 .45 g in 1 BAG; Type 2: Prefilled Drug Delivery Device/System
(syringe, patch, etc.)
GFA Production (Xiamen) Co., Ltd.
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 3/22/20 16
LABELER -
GFA Production (Xiamen) Co., Ltd. (421256261)
Revised: 12/2017