49314-0004 Unishield Sanitizer

49314-0004 Unishield Sanitizer
SPL v2
SPL
SPL Set ID eae1fc97-eb39-4353-adfa-7c549d50b5db
Route
TOPICAL
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) .alpha.-tocopherol Acetate Aminomethylpropanol Denatonium Benzoate Maltodextrin Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

Active ingredient Ethyl Alcohol, 75% v/v


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away  from heat or flame.

Do not use

  • In children less than two months of age
  • On open skin wounds

When using this product:

  • Keep out of eyes, ears, and mouth
  • In case of contact with eyes, rinse eyes throughly with water

Stop use and ask a doctor if irritation or rash occurs. They may be signs of a serious condition.

Indications and Usage

Uses

  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • For use when soap and water are not available
Dosage and Administration

Directions 

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Description

Active ingredient Ethyl Alcohol, 75% v/v

Section 44425-7

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Section 50565-1

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

Section 51727-6

Inactive ingredients

acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, aloe barbadensis leaf jiuce,denatonium benzoate,fragrance, glycerin,maltodextrin, propylene glycol, tocopheryl acetate, water

Section 51945-4

Section 55105-1

Purpose  Antiseptic

Section 55106-9

Active ingredient

Ethyl Alcohol, 75% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • For use when soap and water are not available
Dosage and Administration (34068-7)

Directions 

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away  from heat or flame.

Do not use

  • In children less than two months of age
  • On open skin wounds

When using this product:

  • Keep out of eyes, ears, and mouth
  • In case of contact with eyes, rinse eyes throughly with water

Stop use and ask a doctor if irritation or rash occurs. They may be signs of a serious condition.

Section 44425-7 (44425-7)

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
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 51727-6 (51727-6)

Inactive ingredients

acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, aloe barbadensis leaf jiuce,denatonium benzoate,fragrance, glycerin,maltodextrin, propylene glycol, tocopheryl acetate, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose  Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Ethyl Alcohol, 75% v/v


Advanced Ingredient Data


Raw Label Data

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