CVS HEALTH MEDICATION AND TOPICAL REFILL POUCH- aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen kit

CVS Health Medication and Topical Refill Pouch by

Drug Labeling and Warnings

CVS Health Medication and Topical Refill Pouch 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 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 - 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

Active Ingredient - Aspirin

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver / Fever Reducer

Uses - Aspirin

Temporarily relieves minor aches and pains associated with: headache; muscular aches; minor arthritis pain; backache; common cold; toothache; mentrual cramps; temporarily reduces fever

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The change 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more for a longer time than directed

Do Not Use - Aspirin

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis.

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

Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug.

When using this product: Take with food or milk if stomach upset occurs.

Stop Use and ask a Doctor - Aspirin

Stop Use and ask a Doctor if:

You experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.

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 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. In case of overdose, get medical help or contact a poison control center right away.

Directions - Aspirin

Do not use more than directed - the smallest effective dose should be used.

Drink a full glass of water with each dose.

Do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.

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

Avoid excessive heat and humidity, do not use any open or torn packets.

Inactive Ingredients - Aspirin

hypromellose, polyethylene glycol, propylene glycol, corn starc

Active Ingredient - Diphenhydramine

Diphenhydramine Hydrochloride 25mg

Purpose - Diphenhydramine

Antihistimine

Use - Diphenhydramine

Temporarily relieves the following symptoms associated with hay fever or oother upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes

Warnings

Ask a doctor before use if you have: a breathing problem such as emphyseme or chronic bronchitis, glaucoma, difficulty in urination due to enlargement of the prostate gland; or if you are: taking any drugs for asthma, sedatives or tranquilizers.

When using this product: Drowziness may occur, avoid alcoholic beverages.

Alcohol, sedatives and tranquilizers may increase the drowziness effect. Use caution when driving a motor vehicle or operating machinery. Excitality may occur, especially in children.

Keep out of Reach of Children

Do not exceed recommended dosage. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using the product.

Dosage - Diphenhydramine

Adults and Children (12 Years and older) - take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years - do not give to children under 12 years unless directed by a doctor

Inactive Ingredients

DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch

Active Ingredient - Alcohol Pad

Isopropyl Alcohol 70%

Uses - Alcohol Prep Pad

For preparation of the skin before injection

Warnings - Alcohol Prep Pad

For External Use Only

Flammable - Keep away from fire or flame

Do Not Use - with electrocautery, in eyes

Stop Use and Ask a Doctor if - Irritation or redness develop and persists for more than 72 hours

Keep out of Reach of Children

If Swallowed, get medical help or contact a poison control center right away

Directions - Alcohol Prep Pad

Tear Open packet, unfold and use as and wipe injection site vigorously and discard.

Store at Room Temperature

Inactive Ingredients - Alcohol Pad

Water

Packaging

INGREDIENTS AND APPEARANCE

CVS HEALTH MEDICATION AND TOPICAL REFILL POUCH 
aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-404

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-404-00	1 in 1 BAG; Type 0: Not a Combination Product	12/28/2016

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

Part 1 of 7

DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule

Product Information
Item Code (Source)	NDC: 52124-0016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0016-1	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
OTC monograph final	part341	12/01/2016

Part 2 of 7

ALCOHOL PREP PAD 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 52124-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 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: 52124-0017-1	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	part333A	01/01/2017

Part 3 of 7

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 4 of 7

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 5 of 7

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 7

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

Part 7 of 7

ASPIRIN 
aspirin tablet

Product Information
Item Code (Source)	NDC: 52124-0015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0015-1	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
OTC monograph final	part343	12/01/2016

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(69842-404)