Ciphands Natural - Hand Sanitizer by Hudson Scientific LLC / Bionext Pharma Private Limited

Drug Details [pdf]

CIPHANDS NATURAL - HAND SANITIZER- alcohol gel
Hudson Scientific LLC

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.

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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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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 72.34% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

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

Do not use

In case of any irritation in eyes or on skin discontinue the use of product and seek medical advice
immediately consult a doctor if the product is swallowed.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Directions

Apply CIPHANDS SANITIZER approx 2-3 ml over clean dry hands, nail grooves, back of hands and finger tips. Spread & Rub over
until dry.

Other information

Store at a room temperature, Protect from light

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Triethanolamine,Carbomer, Glycerine, Aloe barbadensis extract,Fragrance.

Package Label - Principal Display Panel

Label

CIPHANDS NATURAL - HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70914-043
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	43 mL in 59 mL

Ingredient Name	Strength
Inactive Ingredients
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70914-043-00	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2020	01/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/28/2020	01/05/2021

Labeler - Hudson Scientific LLC (080339637)

Name	Address	ID/FEI	Business Operations
Establishment
Bionext Pharma Private Limited		858787087	manufacture(70914-043)

Revised: 11/2021

Document Id: 125b9cdd-7c27-4fe7-809d-5d6cebe770f1

Set id: b08b97ca-9869-7f05-e053-2995a90a9d18

Version: 2

Effective Time: 20211130