HAND SANITIZER- alcohol liquid 
SECCO HCSP GROUP JSC

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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For handwashing to decrease bacteria on the skin recommended for repeated use

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 and redness develop and persist for more than 72 hours.

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

Directions

Other information

Inactive ingredients

distilled water, glycerine, carbomer 940, tween 20, azadirachtae indicae oil, aloe vera, essential oil, basil oil, rosemary, vitamin e.

Package Label - Principal Display Panel

30ml NDC: 76699-100-03

76699-100-03

76699-100-03-3

50mL NDC: 76699-100-04

76699-100-04

76699-100-04-3

60mL NDC: 76699-100-09

76699-100-09-3

76699-100-09-2

100 mL NDC: 76699-100-01

7669-100-01-4

76699-100-01-2

300 mL NDC: 76699-100-02

76699-100-02

76699-100-02-2

500 mL NDC: 76699-100-05

76699-100-05

76699-100-05-3

1000 mL NDC: 76699-100-06

76699-100-06

76699-100-06-3

3.85L NDC: 76699-100-07

76699-100-07-2

76699-100-07

208L NDC: 76699-100-08

76699-100-08

76699-100-08-3

60mL: NDC 76699-100-09

76699-100-09

76699-100-09-3

250mL: NDC 76699-100-10

76699-100-10

1.5mL: NDC 76699-100-13

76699-100-13-3

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76699-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
CAJUPUT OIL (UNII: J3TO6BUQ37) 0.5 mL  in 100 mL
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) 0.5 mL  in 100 mL
ROSEMARY (UNII: IJ67X351P9) 1.45 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.6 mL  in 100 mL
BASIL OIL (UNII: Z129UMU8LE) 1.45 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 22.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76699-100-05500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
2NDC:76699-100-02300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
3NDC:76699-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
4NDC:76699-100-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
5NDC:76699-100-08208000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
6NDC:76699-100-073850 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
7NDC:76699-100-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
8NDC:76699-100-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
9NDC:76699-100-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
10NDC:76699-100-10250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
11NDC:76699-100-115000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
12NDC:76699-100-131.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/15/2020
Labeler - SECCO HCSP GROUP JSC (555662957)
Registrant - SECCO HCSP GROUP JSC (555662957)
Establishment
NameAddressID/FEIBusiness Operations
SECCO HCSP GROUP JSC555662957manufacture(76699-100)

Revised: 10/2020
Document Id: b171f2ea-0dc5-2d13-e053-2995a90aa5a4
Set id: a417de3f-4797-156f-e053-2995a90a4a58
Version: 9
Effective Time: 20201011
 
SECCO HCSP GROUP JSC