SAPIL- alcohol aerosol, spray 
Bellevue Parfums USA

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:

  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 80% 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

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Sapil 60 mL Spray

60 mL Spray236 mL Sapil spray can100 mL Sapil spray can100 mL NDC: 78738-200-01 Sapil spray can

NDC 78738-200-02 Sapil spray can

NDC 78738-200-03 Sapil spray can

SAPIL 
alcohol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78738-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.65 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.06 mL  in 100 mL
BUTANE (UNII: 6LV4FOR43R) 28 mL  in 100 mL
PROPANE (UNII: T75W9911L6) 7 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.305 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.065 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.65 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.65 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78738-200-0360 mL in 1 CAN; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Bellevue Parfums USA (080826061)
Registrant - Swiss Arabian Perfumes Ind LLC (643716327)
Establishment
NameAddressID/FEIBusiness Operations
Bellevue Parfums643716327manufacture(78738-200)

Revised: 6/2020
Document Id: a798ac85-74a9-3893-e053-2a95a90a05f1
Set id: a63fd74a-88ac-71f1-e053-2a95a90a521a
Version: 3
Effective Time: 20200608
 
Bellevue Parfums USA