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.

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ALCOHOL PREP PAD

DRUG FACTS

image description

ACTIVE INGREDIENT

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:54429-0101
Route of Administration Topical DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54429-0101-1 1.4 mL in 1 POUCH
2 NDC:54429-0101-2 14 mL in 1 KIT
3 NDC:54429-0101-3 2.8 mL in 1 KIT
4 NDC:54429-0101-6 1.4 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/26/2012
Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
Establishment
Name Address ID/FEI Business Operations
Foshan Flying Medical Products Co., Ltd. 527021584 manufacture(54429-0101)

Revised: 5/2014
Document Id: 8306b85d-a2e0-4740-8f1b-703742e58912
Set id: d5e7456b-182c-4fc4-ad26-fa88729d8817
Version: 6
Effective Time: 20140522
 
Foshan Flying Medical Products Co., Ltd.