SPL v1
SPL
SPL Set ID add6ac49-c0dc-2cff-e053-2995a90a748a
Route
TOPICAL
Published
Effective Date 2020-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.15 mL)
Inactive Ingredients
Trolamine Carbomer 980 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-26

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use
  • To decrease bacteria on the skin
  • Recommended for repeated use
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.







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







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

Warnings

For external use only-hands. Flammable. Keep away from heat or flame. Not recommended for infants.

Directions
  • Wet hands thoroughly with product and allow to dry
  • Store in cool dry place
Do Not Use
  • Children under 4 year of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

carbomer,triethanolaminem water.

Package Label Principal Display Panel

30 mL NDC: 77207-236-01


Structured Label Content

Use
  • To decrease bacteria on the skin
  • Recommended for repeated use
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.







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







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

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only-hands. Flammable. Keep away from heat or flame. Not recommended for infants.

Directions
  • Wet hands thoroughly with product and allow to dry
  • Store in cool dry place
Do Not Use (Do not use)
  • Children under 4 year of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

carbomer,triethanolaminem water.

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

30 mL NDC: 77207-236-01


Advanced Ingredient Data


Raw Label Data

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