SPL v1
SPL
SPL Set ID ab323d6d-3c59-0d76-e053-2a95a90a63a2
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (50 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30
Description

Antiseptic

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Antiseptic

Use

Hand Sanitizer to help reduce bacteria and germs on skin. helps relieve minor muscular aches due to exertion

Section 50565-1

Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Condition persists or gets worse

Section 50567-7
  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than one week
Warnings

For external use only. Flammable. Keep away from heat or flame. Not recommended for deep puncture wounds, animal bites or serious burns. If taken internally, serious gastric disturbances will result.

Directions
  • clean skin and apply a small amount of this product 1-3 daily on selected area as needed
  • allow product to remain on skin surface until dry
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • keep bottle tightly closed
Inactive Ingredients

purified water (Aqua)

Package Label Principal Display Panel

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria and germs on skin. helps relieve minor muscular aches due to exertion

Section 50565-1 (50565-1)

Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Condition persists or gets worse

Section 50567-7 (50567-7)
  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than one week
Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame. Not recommended for deep puncture wounds, animal bites or serious burns. If taken internally, serious gastric disturbances will result.

Directions
  • clean skin and apply a small amount of this product 1-3 daily on selected area as needed
  • allow product to remain on skin surface until dry
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • keep bottle tightly closed
Inactive Ingredients (Inactive ingredients)

purified water (Aqua)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:17.544182 · Updated: 2026-03-14T22:57:45.410763