Full Care Alcohol Prep Pad (Isopropyl Alcohol) Solution [Shaoxing Fuqing Health Products Co., Ltd.] -

FULL CARE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC	65028-004-01, 65028-004-02, 65028-004-03
Set ID	963fa2d4-d99c-41b8-91b9-c0e0f0e77329
Category	HUMAN OTC DRUG LABEL
Packager	Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active Ingredient: Isopropyl Alcohol (70%)
PURPOSE

Purpose: Antiseptic
INDICATIONS & USAGE

Use:

For preparation of the skin prior to an injection
DOSAGE & ADMINISTRATION

Directions:

Wipe injection site vigorously and discard
WARNINGS

Warnings:

For external use only

Flammable. Keep away from fire or flame

Do not use:

With electrocautery procedures

In the eyes. If contact occurs, flush eyes with water.
ASK DOCTOR

Stop use:

If irritation or redness develop

If condition persists consult your healthcare practitioner
KEEP OUT OF REACH OF CHILDREN

Caution Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away
STORAGE AND HANDLING
Other Information:
- Store at room temperature
- Avoid excessive heat (above 104F or 40C)
- Protect from freezing
- Latex free
INACTIVE INGREDIENT

Inactive Ingredient

Purified water
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FULL CARE ALCOHOL PREP PAD
isopropyl alcohol solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.14 g in 0.2 mL

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

#	Item Code	Package Description
Packaging
1	NDC:65028-004-01	0.2 mL in 1 POUCH
2	NDC:65028-004-02	0.4 mL in 1 POUCH
3	NDC:65028-004-03	0.8 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/22/2014

Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)

Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)

Name	Address	ID/FEI	Business Operations
Establishment
Shaoxing Fuqing Health Products Co., Ltd.		530545003	manufacture(65028-004)

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Medic