Hand Sanitizer

Hand Sanitizer
SPL v2
SPL
SPL Set ID aee4c0e7-6de8-325f-e053-2995a90a94a8
Route
TOPICAL
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.2 mL)
Inactive Ingredients
Glycerin .alpha.-tocopherol Acetate Propylene Glycol Water Aloe Vera Leaf Trolamine Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-09

Description

Ethyl Alcohol 70% v/v

Purpose

Anitmicrobial


Medication Information

Purpose

Anitmicrobial

Description

Ethyl Alcohol 70% v/v

Use

Gel hand sanitizer to help reduce bacteria on the skin that could cause disease or illness. Repeat use as needed.

Warnings
  • For external use only.
  • Flammable. Keep away from fire or flame.

Directions
  • Apply to palm of your hand as needed.
  • Rub hands together to spread gel until dry.
  • No rinsing or towel required.
  • Children under 6 years of age consult physcian before use and supervise when using this product.
Other Information
  • Avoid freezing and store below 105°F (41°C)
  • May discolor or harm fabrics, wood finishes and plastics.
Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients
  • Water
  • Triethanolamine
  • Carbomer
  • Propylene Glycol
  • Glycerin
  • Aloe Barbadensis Leaf Juice
  • Tocopheryl Acetate
Dosage & Administration

Topical Gel applied to outer surface of the body, specifically hands.

When Using This Product
  • Keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
  • Avoid contact with broken wounds.
  • Do not ingest or inhale.
Stop Use and Ask A Doctor

if irritation or rash appears and persists more than 72 hours.

Keep Out of the Reach of Children.
  • If swallowed, get medical help or contact the Poison Control Center right away.
Grime Stoppers Instant Hand Sanitizer Gel

53mL NDC: 63436-006-02

500ml NDC: 63436-006-16

3.78mL NDC: 63436-006-28


Structured Label Content

Use (USE)

Gel hand sanitizer to help reduce bacteria on the skin that could cause disease or illness. Repeat use as needed.

Purpose (PURPOSE)

Anitmicrobial

Warnings (WARNINGS)
  • For external use only.
  • Flammable. Keep away from fire or flame.

Directions (DIRECTIONS)
  • Apply to palm of your hand as needed.
  • Rub hands together to spread gel until dry.
  • No rinsing or towel required.
  • Children under 6 years of age consult physcian before use and supervise when using this product.
Other Information (OTHER INFORMATION)
  • Avoid freezing and store below 105°F (41°C)
  • May discolor or harm fabrics, wood finishes and plastics.
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Ethyl Alcohol 70% v/v

Inactive Ingredients (INACTIVE INGREDIENTS)
  • Water
  • Triethanolamine
  • Carbomer
  • Propylene Glycol
  • Glycerin
  • Aloe Barbadensis Leaf Juice
  • Tocopheryl Acetate
Dosage & Administration (DOSAGE & ADMINISTRATION)

Topical Gel applied to outer surface of the body, specifically hands.

When Using This Product (When using this product)
  • Keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
  • Avoid contact with broken wounds.
  • Do not ingest or inhale.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash appears and persists more than 72 hours.

Keep Out of the Reach of Children. (Keep out of the reach of children.)
  • If swallowed, get medical help or contact the Poison Control Center right away.
Grime Stoppers Instant Hand Sanitizer Gel (Grime STOPPERS Instant Hand Sanitizer Gel)

53mL NDC: 63436-006-02

500ml NDC: 63436-006-16

3.78mL NDC: 63436-006-28


Advanced Ingredient Data


Raw Label Data

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