PROTECTION- isopropyl alcohol, benzocaine, alcohol, aspirin kit

Protection by

Drug Labeling and Warnings

Protection by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                                        Purpose

Isopropyl Alcohol, 70% v/v...............        Antiseptic

PURPOSE

Use:    For preparation of skin before injection.

WARNINGS

Warnings:    For external use only.   

STORAGE AND HANDLING

Flammable - keep away from fire or flame

DO NOT USE

Do not use: with electrocautery, in the eyes.

STOP USE

Stop use if irritation and redness develop.

If condition persists for more than 72 hours,

consult your doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed,

get medical help or contact a Poison Control

Center right away.

WHEN USING

Directions:    Wipe injection site vigorously and

STORAGE AND HANDLING

Other information:    Store at room temperature

15 - 30 degree Celsius (59 - 86 Farenheit)

INACTIVE INGREDIENT

Inactive Ingredient:    Purified water

DESCRIPTION

LOT/EXP:                Made in CHINA

20140301

PRINCIPAL DISPLAY PANEL

Alcohol Cleansing

            Pad


Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient:                                    Purpose:

Benzocaine, 6% w/v..................    Topical Anesthetic

SD alcohol, 60% w/v..................    Antiseptic

PURPOSE

Use: For the temporary relief of pain and itching

associated with minor burns, scrapes and insect

bites.

WARNINGS

Warnings: For external use only.

Avoid contact with eyes.  If this happens,

rinse thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help

or contact a Poison Control Center right away.

STORAGE AND HANDLING

Flammable - keep away from fire or flame.

DO NOT USE

Do not use: In eyes, on broken skin, deep

puncture wounds.  If unusual redness, swelling,

irritation or other symptoms occur, consult a

physician immediately.

DESCRIPTION

Made in CHINA

LOT/EXP:

PRINCIPAL DISPLAY PANEL

Insect Sting

Relief Pad

Genuine First Aid LLC, Clearwater FL 33755
                        www.GenuineFirstAid.com


GENUINE FIRST AID

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient (in each tablet)                            Purpose

Aspirin 81 mg (NSAID*) . . . . . . . . . .   Analgesic/Antipyretic

*nonsteroidal anti-inflammatory drug

PURPOSE

Uses

Temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

WARNINGS

Warnings

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome.

Stomach bleeding warning:  This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.  The chance is higher if the user; has had stomach ulcers or bleeding problems

takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
takes more or for a longer time than directed
is age 60 or older
has 3 or more alcoholic drinks every while using this product.

DO NOT USE

Do not use

if you are allergic to aspirin or any other pain relievers/fever reducers

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

for at least 7 days after a tonsillectomy or oral surgery

ASK DOCTOR

Ask a doctor before use if you have;

asthma

stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

a child experiencing arthritis pain

if you are;

allergic to aspirin

taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis

STOP USE

Stop use and ask a doctor if;

an allergic reaction occurs, Seek medical help right away

pain or fever persists

new or unexpected symptoms occur

redness or swelling is present

ringing in ears or loss of hearing occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions  Do not use more than directed

Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children Under 12 years: Consult a doctor.

STORAGE AND HANDLING

Store at room temperature

tamper evident sealed packets

do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients      flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose

DESCRIPTION

MADE IN USA

Distributed by GENUINE FIRST AID

600 Cleveland Str Suite 400, Clearwater, FL 33755

PRINCIPAL DISPLAY PANEL

                                                                      2 Tablets

GENUINE FIRST AID.

Chewable Aspirin 81mg

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Protection

2 Medical Grade Vinyl Gloves
1 Instant Cold Compress
2 Alcohol Cleansing Pads
1 Insect Sting Relief Pads
1 Emergency Blanket 38"x60"
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"X42"x59"

Manufactured in China for:

Genuine First Aid LLC.

600Cleveland Street

Suite 400

Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID

Copyright c 2009 Genuine First Aid LLC. All rights reserved.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTION 
isopropyl alcohol, benzocaine, alcohol, aspirin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-0114

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0114-1	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PACKAGE	1 mL
Part 2	1 PACKAGE	0.5 mL
Part 3	1 PACKAGE	2

Part 1 of 3

ALCOHOL CLEANSING PADS 
isopropyl alcohol liquid

Product Information
Item Code (Source)	NDC: 52124-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0002-1	0.5 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	04/23/2010

Part 2 of 3

INSECT STING RELIEF PAD 
benzocaine, alcohol liquid

Product Information
Item Code (Source)	NDC: 52124-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0008-1	0.5 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part345	04/23/2010

Part 3 of 3

CHEWABLE ASPIRIN 
aspirin tablet, chewable

Product Information
Item Code (Source)	NDC: 52124-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SACCHARIN (UNII: FST467XS7D)
SODIUM CATION (UNII: LYR4M0NH37)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	orange (ORANGE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0012-1	2 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	04/23/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	04/23/2010

Labeler - Genuine First Aid LLC (619609857)

Establishment
Name	Address	ID/FEI	Business Operations
GFA Production ( Xiamen) Co., Ltd		421256261	manufacture