Kit5 Protection

Kit5 Protection
SPL v17
SPL
SPL Set ID 1b6b097e-00cf-4537-8c6f-257fa1f95bfa
Routes
TOPICAL ORAL
Published
Effective Date 2010-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL) Benzocaine (0.6 mg) Alcohol (60 mL) Aspirin (81 mg)
Inactive Ingredients
Water Fd&c Yellow No. 6 Saccharin Sodium Cation Silicon Dioxide Starch, Corn Stearic Acid Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: ASPIRIN Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-23

Description

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic


Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Uses

Temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

Purpose

Antiseptic

Dosage and 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.

Description

LOT/EXP:                Made in CHINA



20140301

Section 44425-7

Flammable - keep away from fire or flame

Section 50565-1

Keep out of reach of children.  If swallowed,



get medical help or contact a Poison Control



Center right away.

Section 50566-9

Stop use if irritation and redness develop.



If condition persists for more than 72 hours,



consult your doctor.

Section 50567-7

Directions:    Wipe injection site vigorously and

Section 50569-3

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



Section 50570-1

Do not use: with electrocautery, in the eyes.

Section 51727-6

Inactive Ingredient:    Purified water

Section 51945-4

Section 53414-9

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.

52124 0008

Use: for the temporary relief of pain and itching associated with minor burn, scrapes, and insect bites.

Aspirin Purpose

Analgesic/Antipyretic

Active Ingredient

Benzocaine, 6% w/v.

SD alcohol, 60% w/v

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Alcohol Cleansing Pad Use

Use: For preparation of the skin befoire injection.

Alcohol Cleansing Wipe Purpose

Antiseptic

52124 0008 Inactive Ingredients

Inactive Ingredient: Purified Water

Insect Sting Relief Pad Purpose

Antiseptic

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID *)




Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Description (34089-3)

LOT/EXP:                Made in CHINA



20140301

Section 44425-7 (44425-7)

Flammable - keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed,



get medical help or contact a Poison Control



Center right away.

Section 50566-9 (50566-9)

Stop use if irritation and redness develop.



If condition persists for more than 72 hours,



consult your doctor.

Section 50567-7 (50567-7)

Directions:    Wipe injection site vigorously and

Section 50569-3 (50569-3)

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



Section 50570-1 (50570-1)

Do not use: with electrocautery, in the eyes.

Section 51727-6 (51727-6)

Inactive Ingredient:    Purified water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

52124 0008 (52124-0008)

Use: for the temporary relief of pain and itching associated with minor burn, scrapes, and insect bites.

Aspirin Purpose

Analgesic/Antipyretic

Active Ingredient

Benzocaine, 6% w/v.

SD alcohol, 60% w/v

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Alcohol Cleansing Pad Use

Use: For preparation of the skin befoire injection.

Alcohol Cleansing Wipe Purpose

Antiseptic

52124 0008 Inactive Ingredients (52124-0008 Inactive Ingredients)

Inactive Ingredient: Purified Water

Insect Sting Relief Pad Purpose

Antiseptic

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Aspirin 81 mg (NSAID *)




Advanced Ingredient Data


Raw Label Data

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