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

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

DRUG FACTS

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ALCOHOL PREP PAD
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54429-0101
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 in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54429-0101-1	1.4 mL in 1 POUCH; Type 0: Not a Combination Product	12/26/2012
2	NDC:54429-0101-2	14 mL in 1 KIT; Type 0: Not a Combination Product	12/26/2012
3	NDC:54429-0101-3	2.8 mL in 1 KIT; Type 0: Not a Combination Product	12/26/2012
4	NDC:54429-0101-6	1.4 mL in 1 POUCH; Type 0: Not a Combination Product	12/26/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/26/2012

Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)

Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Flying Medical Products Co., Ltd.		527021584	manufacture(54429-0101)