b8ab7dd3-fd9f-11a2-e053-2a95a90aaa24

SPL v1
SPL
SPL Set ID b8ab7dd3-fd9f-11a2-e053-2a95a90aaa24
Route
topical
Published
Effective Date 2021-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
didecyldimonium chloride water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-01-12

Description

Alcohol 75%


Medication Information

Warnings and Precautions

For external use only. Flammalbe. Keep away from heat or flame

Active Ingredient

Alcohol 75%

Directions

Place a piece of product to rub hands and external skin, if not liquid leak from the wipe, dispose it, and use a new piece.

Supervise children under 6 years of age when usingthis product to avoid swallowing.

Dosage Forms and Strengths

Store between 15-30°C(59-86°F)

Avoid freezing and excessive heat above40°C(104°F)

Description

Alcohol 75%

Use[s]

Hand and skin sanitizer to help reduce bacteriathat potentially can cause disease.For use when soap and water are not available

Section 50565-1

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

Section 50567-7

When using this product keep out of eye, ear and mouth. In case of contact with eyes, rinse eyesthoroughly with water

Section 50569-3

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition

Section 50570-1

in children less than 2 months of age

on open skin wounds

Section 51727-6

Purified water USP, Didecyldimonium Chloride

Section 51945-4

Section 55105-1

Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only. Flammalbe. Keep away from heat or flame

Active Ingredient (55106-9)

Alcohol 75%

Directions

Place a piece of product to rub hands and external skin, if not liquid leak from the wipe, dispose it, and use a new piece.

Supervise children under 6 years of age when usingthis product to avoid swallowing.

Dosage Forms and Strengths (34069-5)

Store between 15-30°C(59-86°F)

Avoid freezing and excessive heat above40°C(104°F)

Use[s]

Hand and skin sanitizer to help reduce bacteriathat potentially can cause disease.For use when soap and water are not available

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product keep out of eye, ear and mouth. In case of contact with eyes, rinse eyesthoroughly with water

Section 50569-3 (50569-3)

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition

Section 50570-1 (50570-1)

in children less than 2 months of age

on open skin wounds

Section 51727-6 (51727-6)

Purified water USP, Didecyldimonium Chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)