aee75800-3214-5c4b-e053-2a95a90ae923

SPL v2
SPL
SPL Set ID aee75800-3214-5c4b-e053-2a95a90ae923
Route
topical
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (75 mL)
Inactive Ingredients
glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-09

Purpose

Antiseptic

Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Medication Information

Warnings

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

Purpose

Antiseptic

Directions
  • Wipe over the skin or affected area, recommended for single-use, properly dispose of the used wipe.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Water, Hydrogen Peroxide, Glycerin, Fragrance.

Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Use

Sterile antiseptic wipe recommended for single use.

For use when soap and water are not available.

Section 42229-5

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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.

Do Not Use
  • In children less than 2 months of age
  • As a diaper wipe
  • On open skin wounds
  • In eyes. In case of contact, rinse eyes thoroughly with water
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

10 in 1 PACKET NDC: 74988-202-10



50 in 1 PACKET NDC: 74988-202-50



72 in 1 PACKET NDC: 74988-202-72



100 in 1 PACKET NDC: 74988-202-99

75 in 1 CANISTER NDC: 74988-202-75


Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions
  • Wipe over the skin or affected area, recommended for single-use, properly dispose of the used wipe.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Water, Hydrogen Peroxide, Glycerin, Fragrance.

Use

Sterile antiseptic wipe recommended for single use.

For use when soap and water are not available.

Section 42229-5 (42229-5)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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.

Do Not Use (Do not use)
  • In children less than 2 months of age
  • As a diaper wipe
  • On open skin wounds
  • In eyes. In case of contact, rinse eyes thoroughly with water
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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

10 in 1 PACKET NDC: 74988-202-10



50 in 1 PACKET NDC: 74988-202-50



72 in 1 PACKET NDC: 74988-202-72



100 in 1 PACKET NDC: 74988-202-99

75 in 1 CANISTER NDC: 74988-202-75


Advanced Ingredient Data


Raw Label Data

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