ER ALCOHOL PREP- isopropyl alcohol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Taizhou Kangping Medical Science And Technology Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For preparation of skin prior to injection.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ER ALCOHOL PREP- ISOPROPYL ALCOHOL PATCH
TAIZHOU KANGPING MEDICAL SCIENCE AND TECHNOLOGY 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._
----------
ER ALCOHOL PREP PAD
_DRUG FACTS_
_ACTIVE INGREDIENT_
Isopropyl Alcohol 70% v/v
_PURPOSE_
Antiseptic
_USE_
For preparation of skin prior to injection.
_WARNINGS_
For external use only. Flammable, keep away from fire or flame.
_DO NOT USE_
■with electrocautery procedures.
■in the eyes.
■on mucous membranes.
■on irritated skin.
_STOP USE_
If irritation or redness develops, consult a doctor.
_KEE 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 temperature15 - 30°C (59 - 86°F)
_INACTIVE INGREDIENTS_
Purified water.
PACKAGE LABEL
ER ALCOHOL PREP
isopropyl alcohol patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71310-008
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL ALCOHOL
70 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:71310-008-
01
0.4 g in 1 PACKAGE; Type 0: Not a Combination
Product
05/24/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
05/24/2023
LABELER -
Taizhou Kangping Medical Science And Technology Co., Ltd. (543429840)
Taizhou Kangping Medical Science And Technology Co., Ltd.
Revised: 5/2023