SPL v1
SPL
SPL Set ID c80e8d52-07bd-6454-e053-2a95a90a7279
Route
TOPICAL
Published
Effective Date 2021-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 1)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-08-01

Description

Active Ingredient Ethyl Alcohol 75% v/v


Medication Information

Warnings and Precautions

Warnings: • For external use only; hands, general cleansing. • Does not replace wipes used for medical procedures. • Flammable; keep away from fire or flame. • Do not ingest.

Description

Active Ingredient Ethyl Alcohol 75% v/v

Use

Uses: • To help reduce bacteria that can potentially cause disease.

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 and ask a doctor if: • Irritation and redness develop. • Condition persists for more than 72 hours.

Section 50567-7

When using this product: • Keep out of eyes. In case of contact with eyes, flush throughly with water. • Avoid contact with broken skin.

Section 51727-6

Fragrance, Gylcerol, Water.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 75% v/v

Directions

Directions: • Single use wipes for hands. • Close properly after dispensing to maintain purity, as alcohol by its nature evaporates quickly. • Dispose of properly. • DO NOT FLUSH. • Apply throughly to hands to cover all surfaces. • Rub hand together until dry.

Other Information

Keep out of light; store at room temperature 59ºF-86ºF.


Structured Label Content

Use

Uses: • To help reduce bacteria that can potentially cause disease.

Warnings and Precautions (34071-1)

Warnings: • For external use only; hands, general cleansing. • Does not replace wipes used for medical procedures. • Flammable; keep away from fire or flame. • Do not ingest.

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 and ask a doctor if: • Irritation and redness develop. • Condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product: • Keep out of eyes. In case of contact with eyes, flush throughly with water. • Avoid contact with broken skin.

Section 51727-6 (51727-6)

Fragrance, Gylcerol, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 75% v/v

Directions

Directions: • Single use wipes for hands. • Close properly after dispensing to maintain purity, as alcohol by its nature evaporates quickly. • Dispose of properly. • DO NOT FLUSH. • Apply throughly to hands to cover all surfaces. • Rub hand together until dry.

Other Information

Keep out of light; store at room temperature 59ºF-86ºF.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)