SIENA HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Hilal Care Pvt Ltd
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:
81338-001-01, 81338-001-02, 81338-001-03

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SIENA HAND SANITIZER- alcohol gel

Hilal Care Pvt Ltd

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.

----------

Siena 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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. Hydrogen peroxide (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)

Alcohol 80% v/v. Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

Us e

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, trolamine, purified water USP, acrylates/c10-30 alkyl acrylate crosspolymer, Fragrance

Package Label - Principal Display Panel

60 mL NDC: 81338-001-01

275 ml NDC 81338-001-02

500 ml NDC 81338-001-03

Hilal Care Pvt Ltd

SIENA HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1338 -0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

8 0 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

FRAGRANCE LEMO N O RC2 0 0 10 6 0 (UNII: K1725A7G9 5)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 1338 -0 0 1-

6 0 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

12/21/20 20

2

NDC:8 1338 -0 0 1-

275 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

12/21/20 20

3

NDC:8 1338 -0 0 1-

50 0 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

12/21/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/21/20 20

Labeler -

Hilal Care Pvt Ltd (645791893)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

STANCOS PRIVATE LIMITED

6 45478 6 8 6

ma nufa c ture (8 1338 -0 0 1)

Revised: 12/2020

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