ALCOHOL PREP PAD- isopropyl alcohol swab 
Foshan Flying 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.

----------

ALCOHOL PREP PAD

DRUG FACTS

ACTIVE INGREDIENT

Isopropyl Alcohol 70% v/v

PURPOSE

Antiseptic

USE

For preparation of the skin prior to an injection

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

Do not use

﹒with electrocautery procedures

﹒in the eyes

Stop use

if irritation and redness develop

Ask a doctor

if condition persists for more than 72 hours

Caution:

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Wipe injection site vigorously

OTHER INFORMATION

Store at room temperature

INACTIVE INGREDIENT

water

image of labeling

ACTIVE INGREDIENT

Isopropyl Alcohol 70% v/v

PURPOSE

Antiseptic

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

USE

For preparation of the skin prior to an injection

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

DIRECTIONS

Wipe injection site vigorously

INACTIVE INGREDIENT

Water

ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54429-0101
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54429-0101-11.4 mL in 1 POUCH
2NDC:54429-0101-214 mL in 1 KIT
3NDC:54429-0101-32.8 mL in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/26/2012
Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Flying Medical Products Co., Ltd.527021584manufacture(54429-0101)

Revised: 10/2013
Document Id: 6af4526c-d325-4db6-8de3-4b96b929dd77
Set id: d5e7456b-182c-4fc4-ad26-fa88729d8817
Version: 4
Effective Time: 20131021
 
Foshan Flying Medical Products Co., Ltd.