MedPath

Juniper Clean Hand Sanitizer

Hand Sanitizer

Approved
Approval ID

a6bb7f88-ac9b-4f72-e053-2995a90ac15c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

KYNC Design LLC

DUNS: 039933298

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76557-000
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (5)

TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER 1342Inactive
Code: 809Y72KV36
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/28/2020

Package Label - Principal Display Panel

250 mL NDC: 76557-000-02 Hand Gel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/28/2020

Use

Hand Sanitizer to help reduce bacteria on the skin.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/28/2020

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/28/2020

Other information

Store below 110F (43C)

May discolor certain fabrics or surfaces

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/28/2020

Inactive ingredients

Water (Aqua), Glycerine, Carbomer, Triethanolamine

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 5/29/2020

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 3/28/2020

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/28/2020

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/28/2020

Purpose

Antimicrobial, Hand Sanitizer

WARNINGS SECTION

LOINC: 34071-1Updated: 3/28/2020

Warnings

Flammable. Keep away from fire or flame.

For extarnal use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 3/28/2020

Do not use

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 3/28/2020

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/28/2020

SPL Unclassified Section

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/28/2020

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antimicrobial

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