ALCOHOL PREP PAD- 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:

Hubei Chenteng Healthcare Co.,Ltd.

INN (International Name):

ISOPROPYL ALCOHOL

Composition:

ISOPROPYL ALCOHOL 700 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antiseptic To help prevent infection in minor cuts and scrapes.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL PREP PAD- ISOPROPYL ALCOHOL SWAB
HUBEI CHENTENG HEALTHCARE 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 PREP PAD
ACTIVE INGREDIENT:
Isoprophyl Alcohol, 70% v/v
PURPOS E:
First Aid Antiseptic
US E
To help prevent infection in minor cuts and scrapes.
WARNINGS
For external use only
Flammable, keep away from fire or flame
Do not use with electrocautery procedures or in eyes
Stop use if redness or irritation develops. If condition continues for
more than 72 hours consult a
physician.
DIRECTIONS
Apply alcohol as needed to clean intended area. Discard after single
use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or call a Poison Control Center right
away.
INACTIVE INGREDIENT
Purified water
PACKAGE LABEL
ALCOHOL PREP PAD
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7150 9 -0 0 3
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
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:7150 9 -
0 0 3-0 0
1 in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System
(syringe, patch, etc.)
0 6 /22/20 17
0 4/30 /20 22
Hubei Chenteng Healthcare 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 6 /22/20 17
0 4/30 /20 22
LABELER -
Hubei Chenteng Healthcare Co.,Ltd. (544504326)
Revised: 5/2019