SPL v1
SPL
SPL Set ID da2b146e-c45d-4b4b-e053-2a95a90a60ba
Route
TOPICAL
Published
Effective Date 2022-03-09
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 NOT FINAL Active Since 2022-03-09

Description

Isopropyl Alcohol, 70% v/v


Medication Information

Warnings and Precautions

For external use only. Flammable, keep away from fire or flame.



Do not use

  • with electrocautery procedures in the eyes
  • on mucous membranes
  • on irritated 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.

Indications and Usage

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Dosage and Administration

Apply topically as needed to cleanse intendend area;



Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.

Description

Use for preparation of skin prior to injection

Section 50565-1

keep out of reach of children section

Section 50570-1

Do not use the product when its packaging is damaged.

Section 51727-6

Purified Water

Section 51945-4

0.4ml NDC:81636-005-01

Section 55105-1

Use for preparation of skin prior to injection,to clean the skin

Section 55106-9

Isopropyl Alcohol, 70% v/v

Section 60561-8

Store at room temperature 15 - 30°C (59 - 86°F)


Structured Label Content

Indications and Usage (34067-9)

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse intendend area;



Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.

Warnings and Precautions (34071-1)

For external use only. Flammable, keep away from fire or flame.



Do not use

  • with electrocautery procedures in the eyes
  • on mucous membranes
  • on irritated 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.

Description (34089-3)

Use for preparation of skin prior to injection

Section 50565-1 (50565-1)

keep out of reach of children section

Section 50570-1 (50570-1)

Do not use the product when its packaging is damaged.

Section 51727-6 (51727-6)

Purified Water

Section 51945-4 (51945-4)

0.4ml NDC:81636-005-01

Section 55105-1 (55105-1)

Use for preparation of skin prior to injection,to clean the skin

Section 55106-9 (55106-9)

Isopropyl Alcohol, 70% v/v

Section 60561-8 (60561-8)

Store at room temperature 15 - 30°C (59 - 86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)