ad1a0c35-b8de-7ddd-e053-2995a90aad35

SPL v2
SPL
SPL Set ID ad1a0c35-b8de-7ddd-e053-2995a90aad35
Route
topical
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (0.3 mL)
Inactive Ingredients
fragrance lemon orc2001060 glycerin hydrogen peroxide water aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-17

Purpose

Antiseptic

Description

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. (27.465%) Fragrance (Parfum) Aloe vera leaf extract


Medication Information

Warnings

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

Purpose

Antiseptic

Directions
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe.
  • Discard after single use
  • Supervise children under 6 years of age when using this product to avoid swallowing
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

water(aqua), glycerin, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis

Description

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. (27.465%) Fragrance (Parfum) Aloe vera leaf extract

Use

Sanitizing alcohol wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Section 42229-5

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  • Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water. (27.465%)
  • Fragrance (Parfum)
  • Aloe vera leaf extract

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
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

80ct NDC: 76665-007-80


Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe.
  • Discard after single use
  • Supervise children under 6 years of age when using this product to avoid swallowing
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

water(aqua), glycerin, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis

Use

Sanitizing alcohol wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Section 42229-5 (42229-5)

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  • Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water. (27.465%)
  • Fragrance (Parfum)
  • Aloe vera leaf extract

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
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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

80ct NDC: 76665-007-80


Advanced Ingredient Data


Raw Label Data

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