CARE HAND- isopropyl alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Available from:
PENSEUR KREATIVA GROUP
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
81227-000-01, 81227-000-02, 81227-000-03, 81227-000-04, 81227-000-05, 81227-000-06, 81227-000-07, 81227-000-08, 81227-000-09

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CARE HAND- isopropyl alcohol gel

PENSEUR KREATIVA GROUP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may

be marketed if they comply with applicable regulations and policies. FDA has not

evaluated whether this product complies.

----------

PENSEUR HAND SANITIZER

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation

of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

(CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO)

recommendations:

a. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol

and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.45% v/v).

c. Carbopomer (0.125% v/v).

d. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional

ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when

soap and water are not available.

Warnings

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

Do not use

in children less than 2 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 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.

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.

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.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

3785 NDC: 81227-101-01

CARE HAND

isopropyl alcohol gel

Product Information

Product Type

HUMAN OTC DRUG

Item Code (Source)

NDC:81227-000

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Strength

Strength

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -

UNII:ND2M416302)

ISOPROPYL

ALCOHOL

70 mL

in 100 mL

Inactive Ingredients

Ingredient Name

Strength

GLYCERIN (UNII: PDC6A3C0OX)

1.45 mL in 100 mL

CARBOMER 940 (UNII: 4Q93RCW27E)

0.125 mL in 100 mL

WATER (UNII: 059QF0KO0R)

28.425 mL in 100 mL

Product Characteristics

Color

Score

Shape

Size

Flavor

Imprint Code

Contains

Packaging

# Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:81227-

000-01

3785 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

2

NDC:81227-

000-02

59 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

3

NDC:81227-

000-03

118 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

4

NDC:81227-

000-04

237 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

5

NDC:81227-

000-05

296 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

6

NDC:81227-

000-06

473 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

7

NDC:81227-

000-07

946 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

8

NDC:81227-

000-08

1892.71 mL in 1 BOTTLE; Type 0: Not a Combination

Product

01/01/2021

9

NDC:81227-

000-09

2 mL in 1 VIAL, SINGLE-USE; Type 0: Not a

Combination Product

01/01/2021

PENSEUR KREATIVA GROUP

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

OTC monograph not

final

part333A

12/15/2020

Labeler -

PENSEUR KREATIVA GROUP (817469188)

Registrant -

PENSEUR KREATIVA GROUP (817469188)

Establishment

Name

Address

ID/FEI

Business Operations

PENSEUR KREATIVA GROUP

817469188

manufacture(81227-000)

Revised: 4/2021

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