SURYA HENNA HAND SANITIZER- ethyl alcohol gel

Surya Henna Hand Sanitizer by

Drug Labeling and Warnings

Surya Henna Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Surya Nature Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

USE: Apply a small amount of SURYA HENNA HAND SANITIZER in the
hands palm, massaging lightly, until completely absorbed.
NO RINSE REQUIRED.

Warnings

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

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

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

WHEN USING

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

Stop use and ask a doctor if irritation or redness develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

Directions apply palmful to hands rub hands together vigorously until dry
supervise children in the use of this product.

Other information

• Other Information
  Store below 110 º F (43 º C). May discolor certain fabrics or surfaces.

Inactive ingredients

Inactive ingredients: Alcohol, Aqua, Glycerin (Vegetal), Carbomer, Aminomethyl
Propanol, Aloe Barbadensis Leaf Extract (Aloe Vera), Lawsonia Inermis Leaf Extract
(Henna), Chamomilla Recutita Flower Extract (Camomila), Denatonium Benzoate

Package Label - Principal Display Panel

230 mL NDC: 75252-720-10

60mL NDC: 75252-720-20

INGREDIENTS AND APPEARANCE

SURYA HENNA HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75252-720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.15 mL  in 100 mL
LAWSONIA INERMIS LEAF (UNII: E5818YZ355)	0.01 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.02 mL  in 100 mL
CHAMOMILE (UNII: FGL3685T2X)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75252-720-10	230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2020
2	NDC: 75252-720-20	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - Surya Nature Inc (884726055)

Registrant - Surya Nature Inc (884726055)