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.

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KYJ Medical Alcohol Prep Pad MEDIUM Sterile ,Single Use, Latex-Free Saturated with 70% v/v Isopropyl Alcohol

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Use

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.

kyj

ALCOHOL PREP
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76161-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	0.3 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76161-001-01	1 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/20/2011

Labeler - KYJ Medical Products Co.,Ltd. (421270350)

Name	Address	ID/FEI	Business Operations
Establishment
KYJ Medical Products Co.,Ltd.		421270350	manufacture(76161-001)