Simpurity Hand Sanitizer, 4 Oz.

Simpurity Hand Sanitizer, 4 Oz.
SPL v3
SPL
SPL Set ID a47cf893-4ec1-6e8d-e053-2a95a90a4cf5
Route
TOPICAL
Published
Effective Date 2020-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.25 mL)
Inactive Ingredients
Tocopherol Aloe Vera Leaf Propylene Glycol Hydroxyethyl Cellulose, Unspecified Water Hyaluronate Sodium Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation): Alcohol (ethanol) (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. hydroxyethylcellulose aloe powder propylene glycol hyaluronic acid tea tree essential oil vitamin E Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation): Alcohol (ethanol) (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. hydroxyethylcellulose aloe powder propylene glycol hyaluronic acid tea tree essential oil vitamin E Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.

Uses

Helps reduce bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

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.

Warnings

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

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

distilled water

hydroxyethylcellulose

aloe powder

propylene glycol

hyaluronic acid

tea tree essential oil

vitamin E

74069 002 04 Principal Display Panel

120 mL NDC: 074069-002-04

Simpurity 75% Alcohol Hand Sanitizer

This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  • Alcohol (ethanol) (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.
  • hydroxyethylcellulose
  • aloe powder
  • propylene glycol
  • hyaluronic acid
  • tea tree essential oil
  • vitamin E
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.

74069 002 08 240 Ml Package Label Principal Display Panel

240 mL NDC: 074069-002-08


Structured Label Content

Uses

Helps reduce bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

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.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

distilled water

hydroxyethylcellulose

aloe powder

propylene glycol

hyaluronic acid

tea tree essential oil

vitamin E

74069 002 04 Principal Display Panel (74069-002-04 Principal Display Panel)

120 mL NDC: 074069-002-04

Simpurity 75% Alcohol Hand Sanitizer (Simpurity 75% alcohol Hand Sanitizer)

This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  • Alcohol (ethanol) (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.
  • hydroxyethylcellulose
  • aloe powder
  • propylene glycol
  • hyaluronic acid
  • tea tree essential oil
  • vitamin E
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.

74069 002 08 240 Ml Package Label Principal Display Panel (74069-002-08 240 mL Package Label - Principal Display Panel)

240 mL NDC: 074069-002-08


Advanced Ingredient Data


Raw Label Data

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