Instant Hand Sanitizer
FDA Label NDC 74949-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Earths Amenities for the product Instant Hand Sanitizer (NDC 74949-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label - Principal Display Panel

Other

This is a hand sanitizer manufactured according to the OTC Monograph Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

The hand sanitizer is manufactured using

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin
Aloe Vera Extract
Water
Carbomer
Aminomethyl Propanol

Active Ingredient(S)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on the skin.

Warnings

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

Otc - When Using

Do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink.

Otc - Stop Use

Stop use and ask a doctor if skin irritation or redness develops.

Otc - Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other Information

Store below 73.4F (23C)

Inactive Ingredients

Water, glycerin, aloe vera extract, carbomer, aminomethyl propanol

Package Label - Principal Display Panel

60 mL NDC: 74949-001-60

250 mL NDC: 74949-001-25

495 mL NDC: 74949-001-49

1L NDC: 74949-001-01

* Please review the disclaimer below.

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