CVS FIRST AID KIT- diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, benzalkonium chloride, ammonia, lidocaine, acetaminophen, ibuprofen, kit

CVS First Aid Kit by

Drug Labeling and Warnings

CVS First Aid Kit by is a Otc medication manufactured, distributed, or labeled by CVS, Tender Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients - Genuine Triple Antibiotic

Active Ingredient: .........Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

Purpose - Genuine Triple Antibiotic

Triple Antibiotic

Uses - Genuine Triple Antibiotic

To help prevent infection in:
minor cuts; scrapes; burns

Warnings - Genuine Triple Antibiotic

For external use only

DO NOT USE - Genuine Triple Antibiotic

Do not use: in eyes; over large areas of the body;

If allergic to any of the ingredients; for more than one week unless directed by a physician.

Stop Use - Genuine Triple Antibiotic

Stop use and consult a doctor:

if the condition persists or gets worse; a rash or other allergic reaction develops

Keep Out of Reach of Children - Genuine Triple Antibiotic

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

Directions - Genuine Triple Antibiotic

Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

Storage and Handling - Genuine Triple Antibiotic

Other information:

Store at room temperature.

Inactive Ingredients - Genuine Triple Antibiotic

Vaseline
Mineral Oil
Purified Water

Active Ingredients - Antiseptic

Active Ingredient:

Benzalkonium Chloride 0.13

Purpose - Antiseptic

Antiseptic

Use - Antiseptic

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings - Antiseptic

Warning: For external use only.

Keep out of reach of children - Antiseptic

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use - Antiseptic

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Do Not Use - Antiseptic

Do not use in the eyes or over large areas of the body.

Directions - Antiseptic

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive Ingredients - Antiseptic

Inactive Ingredient: Purified water

Active Ingredient - Ibuprofen

Ibuprofen USP (NSAID*) 200mg
*nonsteroidal anti-inflammatory drug

Purpose - Ibuprofen

Pain reliever/fever reducer

Uses - Ibuprofen

temporarily relieves minor aches and pains due to:

the common cold

headache

toothache

muscular aches

backache

minor pain of arthritis

menstrual cramps temporarily reduces fever

Warnings - Ibuprofen

Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed

Do Not Use - Ibuprofen

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.

Ask a Doctor - Ibuprofen

Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Ask a doctore before use if you are taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

When Using - Ibuprofen

when using this product take with food or milk if stomach upset occurs

Stop Use - Ibuprofen

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

Pregnancy or Breast Feeding - Ibuprofen

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

Keep out of reach of Children - Ibuprofen

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

Directions - Ibuprofen

do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Other Information

Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

INACTIVE INGREDIENTS - Ibuprofen

​cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Active Ingredients - Non-Aspirin

Acetaminophen 500 mg

Purpose - Non Aspirin

Analgesic/antipyretic

Uses - Non Aspirin

temporary relief of minor aches and pains associated with:

common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever

Warnings - Non Aspirin

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product

Do Not Use - Non Aspirin

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor

Ask a Doctor - Non Aspirin

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop Use - Non Aspirin

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs

Pregnancy - Non Aspirin

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children - Non Aspirin

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt
medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms. Do not exceed recommended dosage

Inactive Ingredients - Non Aspirin

Cornstarch, polyethylene glycol, stearic acid, povidone

Directions - Non Aspirin

Directions

Adults and Children Take 2 tablets every 4 to 6 hours as

12 years of age needed. Do not take more than 12 tablets

or older in 24 hours.

Children 6-11 years Take 1 tablet every 4 to 6 hours as

of age needed. Do not take more than 5

tablets in 24 hours.

Children under 6 Do not use this regular strength product.

years of age This will provide more than the

recommended dose (overdose) and could

cause serious health problems.

Storage and Handling - Non Aspirin

Store at 59-86 degree F (15-30 degree C)

tamper evident sealed packets; do not use any open or torn packets

Active Ingredients - Burn Cream

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Purpose - Burn Cream

Purpose: First aid antiseptic, external analgesic

Uses - Burn Cream

First aid to help prevent infection and for the temporary relief of pain and itching associated with:

Minor Cuts

Scrapes

Burns

Warnings - Burn Cream

For external use only

Do Not Use - Burn Cream

Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

Do not use:
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
in large quantities, particularly over raw surfaces or blistered areas.

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

When using this product, avoid contact with the eyes.

Stop Use - Burn Cream

Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
condition clears up and occurs again within a few days

Keep Out of Reach of Children

Keep out of reach of Children.

If ingested, contact a Poison Control Center right away.

Directions - Burn Cream

Adults and children 2 years of age and older

clean affected area.

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

Storage and Handling - Burn Cream

Other Information:

Store at room temperature (do not freeze).

Taper evident sealed packets.

Do not use packet if opened or torn.

Inactive Ingredients - Burn Cream

Peregal-O

Glycerin monostearate

Glycerol

Purified Water.

Active Ingredients - After Bite

Active Ingredient:

Ammonia 3.5%

Purpose - After Bite

Counterirritant

Uses - After Bite

Temporarily protects and helps relieve minor skin irriatation and itching due to

• insect bites and stings
• poison ivy, oak or sumac

Warnings - After Bite

Warning: For external use only.

Keep Out of Reach of Children - After Bite

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use - After Bite

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

When Using - After Bite

Do not get into eyes

DIrections - After Bite

Adults and children under 2 years and older dab directly on bite or sting, rub gently and re-apply as needed

Children under 2 years ask a doctor

First Aid Kit Sleeve

Principal Display Panel - Triple Antibiotic

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.

Package Label - Antiseptic

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Package Label - Ibuprofen

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

IBUPROFEN 2 Tablets

Package Label Non Aspirin

Package Label - Burn Cream

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid

GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

Package Label - After Bite

After Bite

The Itch Eraser

Fast Relief from Insect Bites.

Net Contents: 0.037fl. oz.

Contains: One (1) Wipe

Contains Ammonia

Tender Corporation

Littleton, NH 03561

INGREDIENTS AND APPEARANCE

CVS FIRST AID KIT 
diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, benzalkonium chloride, ammonia, lidocaine, acetaminophen, ibuprofen, kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-200

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-200-00	1 in 1 BAG; Type 0: Not a Combination Product	12/28/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKAGE	3 mL  in .7
Part 2	2 PACKET	2 g  in .9
Part 3	1 PACKAGE	2
Part 4	1 PACKET	2
Part 5	15 PACKAGE	12 mL  in .8
Part 6	6 TUBE	3 g  in .5

Part 1 of 6

AFTER BITE WIPE 
ammonia swab

Product Information
Item Code (Source)	NDC: 44224-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE 1000 (UNII: MCU2324216)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
C12-13 ALCOHOLS (UNII: T7ZJT3I9X2)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-0001-2	0.7 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/28/2016

Part 2 of 6

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
benzalkonium chloride, lidocaine cream

Product Information
Item Code (Source)	NDC: 52124-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0040-1	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2016

Part 3 of 6

NON-ASPIRIN 
acetaminophen tablet

Product Information
Item Code (Source)	NDC: 52124-0014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0014-1	2 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/28/2016

Part 4 of 6

IBUPROFEN 
ibuprofen tablet

Product Information
Item Code (Source)	NDC: 52124-0013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACETIN (UNII: XHX3C3X673)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;352
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0013-1	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075010	12/28/2016

Part 5 of 6

ANTISEPTIC 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 52124-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0001-1	0.8 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2016

Part 6 of 6

GENUINE TRIPLE ANTIBIOTIC 
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 52124-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0003-1	0.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2016

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(69842-200)