live tula drug listing and certification

live tula drug listing and certification
SPL v2
SPL
SPL Set ID 2be91a00-87da-fcc1-e063-6394a90ace3a
Route
topical
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-03

Description

Drug Facts Active Ingredient Isopropyl Alcohol 70% v/v Purpose Antiseptic Use For preparation of the skin prior to injection to reduce the risk of infection. Warnings For external use only. Flammable: Keep away from fire or flame. Do not use With electrocautery procedures. In or near the eyes. On mucous membranes. On irritated or damaged skin. Stop use and ask a doctor if Irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Medication Information

Warnings and Precautions

Warnings: For external use only. Flammable: Keep away from fire or flame. Do not use: - With electrocautery procedures. - In the eyes, on mucous membranes, or on irritated skin. Stop use and ask a doctor if irritation or redness develops.

Active Ingredient

Active Ingredient/Strength

Isopropyl Alcohol (UNII: ND2M416302): 70 mL per 100 mL

Indications and Usage

Indications & Usage: Use for preparation of the skin prior to injection to reduce the risk of infection.

Dosage and Administration

Apply topically as needed to cleanse the intended area. Allow to dry before proceeding with the injection or procedure.

Description

Drug Facts

Active Ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Use

For preparation of the skin prior to injection to reduce the risk of infection.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Do not use

With electrocautery procedures.

In or near the eyes.

On mucous membranes.

On irritated or damaged skin.

Stop use and ask a doctor if

Irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 44425-7

Other Information

Store at room temperature: 15–30°C (59–86°F).

Do not use the product if the packaging is damaged.

Section 50565-1

Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

Directions

  • Apply topically as needed to cleanse the intended area.
  • Use for skin preparation prior to injection:

Apply the product to the skin.

Take the injection or puncture site as the center, and slowly rotate outward in a circular motion.

Repeat application twice.

Ensure the disinfection area is at least 5cm x 5cm.

Allow a contact time of 1 minute for proper disinfection

3.Clean the area before disinfection, if necessary.

Section 51727-6
  • Inactive Ingredient

Purified Water (UNII: 059QF0KO0R): 30 mL per 100 mL

Purified Water (used as a solvent).

Section 51945-4



Section 55105-1

Purpose: Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only. Flammable: Keep away from fire or flame. Do not use: - With electrocautery procedures. - In the eyes, on mucous membranes, or on irritated skin. Stop use and ask a doctor if irritation or redness develops.

Active Ingredient (55106-9)

Active Ingredient/Strength

Isopropyl Alcohol (UNII: ND2M416302): 70 mL per 100 mL

Indications and Usage (34067-9)

Indications & Usage: Use for preparation of the skin prior to injection to reduce the risk of infection.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse the intended area. Allow to dry before proceeding with the injection or procedure.

Description (34089-3)

Drug Facts

Active Ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Use

For preparation of the skin prior to injection to reduce the risk of infection.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Do not use

With electrocautery procedures.

In or near the eyes.

On mucous membranes.

On irritated or damaged skin.

Stop use and ask a doctor if

Irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 44425-7 (44425-7)

Other Information

Store at room temperature: 15–30°C (59–86°F).

Do not use the product if the packaging is damaged.

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 50567-7 (50567-7)

Directions

  • Apply topically as needed to cleanse the intended area.
  • Use for skin preparation prior to injection:

Apply the product to the skin.

Take the injection or puncture site as the center, and slowly rotate outward in a circular motion.

Repeat application twice.

Ensure the disinfection area is at least 5cm x 5cm.

Allow a contact time of 1 minute for proper disinfection

3.Clean the area before disinfection, if necessary.

Section 51727-6 (51727-6)
  • Inactive Ingredient

Purified Water (UNII: 059QF0KO0R): 30 mL per 100 mL

Purified Water (used as a solvent).

Section 51945-4 (51945-4)



Section 55105-1 (55105-1)

Purpose: Antiseptic


Advanced Ingredient Data


Raw Label Data

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