SPL v14
SPL
SPL Set ID a556d354-4c65-508b-e053-2995a90a6b0a
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Trolamine Water Propylene Glycol Carbomer 980

Identifiers & Packaging

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

Description

NA

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

NA

Use

Helps reduce bacteria on the skin. Recommended for repeated use.

Section 42229-5

NA

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 or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact,, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts.



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

Warnings

Flammable. Keep away from heat or flame, For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • for children under 6, use only with adult supervision. not recommended for infants.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 110F(43C)
  • May discolor certain fabrics of surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

purified water,glycerin,propylene glycol, carbomer,triethanolamine

Package Label Principal Display Panel

60 mL NDC: 074765-014-01

300 mL NDC: 074765-014-02


Structured Label Content

Use

Helps reduce bacteria on the skin. Recommended for repeated use.

Section 42229-5 (42229-5)

NA

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 or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact,, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts.



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

Purpose

Antiseptic, Hand Sanitizer

Warnings

Flammable. Keep away from heat or flame, For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • for children under 6, use only with adult supervision. not recommended for infants.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 110F(43C)
  • May discolor certain fabrics of surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

purified water,glycerin,propylene glycol, carbomer,triethanolamine

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

60 mL NDC: 074765-014-01

300 mL NDC: 074765-014-02


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)