Auto 157

Auto 157
SPL v12
SPL
SPL Set ID d0d44c0f-e435-473f-93a4-71a79c6bc04a
Routes
TOPICAL ORAL
Published
Effective Date 2010-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Lidocaine (0.5 g) Benzocaine (0.40 mL) Alcohol (6 mL) Ibuprofen (60 mL) Acetaminophen (200 mg) Aspirin (325 mg)
Inactive Ingredients
Water Powdered Cellulose Starch, Corn Hypromellose Lactose Magnesium Stearate Polydextrose Polyethylene Glycol Povidone Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;157;ASPIRIN Shape: round Color: white Size: 10 mm Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-05-07

Description

ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%


Medication Information

Warnings and Precautions

Warnings:



For external  use only

Dosage and Administration

Directions: Clean affected area, Apply small amount not more than 3 times daily.



May be covered with a sterile bandage.

Description

LOT/EXP:                                    Made in CHINA



20130301

Section 34072-9

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

Section 44425-7

Other Information:



Store at room temperature

Section 50565-1

Keep out of reach of Children.



If ingested, contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 50568-5

Ask a doctor 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

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive Ingredient:    Purified water

Section 51945-4

Genuine First Aid Burn Cream



Antiseptic Pain Relief With Aloe



Net Wt 0.9g (1/32 oz)



Manufactured in CHINA for



Genuine First Aid.

Section 53414-9

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.

Section 55105-1

Purpose: First aid antiseptic, external analgesic



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



Minor Cuts



Scrapes



Burns

Section 55106-9

ACTIVE INGREDIENTS:



Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%


Structured Label Content

Dosage and Administration (34068-7)

Directions: Clean affected area, Apply small amount not more than 3 times daily.



May be covered with a sterile bandage.

Warnings and Precautions (34071-1)

Warnings:



For external  use only

Section 34072-9 (34072-9)

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

Description (34089-3)

LOT/EXP:                                    Made in CHINA



20130301

Section 44425-7 (44425-7)

Other Information:



Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of Children.



If ingested, contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor 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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive Ingredient:    Purified water

Section 51945-4 (51945-4)

Genuine First Aid Burn Cream



Antiseptic Pain Relief With Aloe



Net Wt 0.9g (1/32 oz)



Manufactured in CHINA for



Genuine First Aid.

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose: First aid antiseptic, external analgesic



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



Minor Cuts



Scrapes



Burns

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:



Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%


Advanced Ingredient Data


Raw Label Data

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