HYDRA PEARL HAND SANITIZER- antiseptic gel gel 
NOVAGEL HAND SANITIZER- antiseptic gel gel 
IVOGEL HAND SANITIZER- antiseptic gel gel 
HYDRA PEARL LIQUID- sanitizing hand spray liquid 
PlasmaDent Inc

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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Nova Gel

Principle Display PanelAdvanced Hand Sanitizer

Original Scent

Leaves Hands Feeling Soft

8 FL OZ (236.6 mL)

Active Ingredient

Active Ingredient Purpose

Ethyl Alcohol 70% v/v ----------------Antiseptic

Purpose

Use- To decrease bacteria on the skin

Use

Use-To decrease bacteria on the skin

Keep out of the reach of children

Keep out of the reach of children

Warnings

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.

Stope 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 poisen control center right away.

Directions

Directions-wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants.

Other information

Other information- Do not store above 110 oF (43 oC)

May discolor some fabrics.

Harmful to wood finishes and plastics

Inactive Ingredient Section

Inactive Ingredient- Water, Glycerin, Carbomer, Aminomethyl propanol, fragrance

Hydra Pearl

Label

Advanced Hand Sanitizer

Original Scent

Leaves Hands Feeling Soft

8 FL OZ (236.6 mL)

Hydra Pearl
Sanitizing Spray

Liquid Sanitizer Spray

Ivogel Hand Sanitizer

Ivogel Hand Sanitizer

70% Alcohol Unscented

Moisterizing Gel

Leaves hands feeling soft

IvoGel Label

HYDRA PEARL HAND SANITIZER 
antiseptic gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73893-002
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.3 g  in 100 mL
WATER (UNII: 059QF0KO0R) 32.8 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73893-002-02236.6 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
2NDC:73893-002-03473.2 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
3NDC:73893-002-04295.7 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
4NDC:73893-002-05946.4 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
5NDC:73893-002-063800 mL in 1 CONTAINER; Type 0: Not a Combination Product08/12/2020
6NDC:73893-002-1159.1 mL in 1 TUBE; Type 0: Not a Combination Product08/12/2020
7NDC:73893-002-0818900 mL in 1 CONTAINER; Type 0: Not a Combination Product10/02/2020
8NDC:73893-002-12189000 mL in 1 DRUM; Type 0: Not a Combination Product02/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/12/2020
NOVAGEL HAND SANITIZER 
antiseptic gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73893-001
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.3 g  in 100 mL
WATER (UNII: 059QF0KO0R) 32.8 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73893-001-0159.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:73893-001-02236.6 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
3NDC:73893-001-03473.2 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2020
4NDC:73893-001-04295.7 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/15/2020
5NDC:73893-001-05946.4 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/15/2020
6NDC:73893-001-063800 mL in 1 CONTAINER; Type 0: Not a Combination Product04/15/2020
7NDC:73893-001-079500 mL in 1 CONTAINER; Type 0: Not a Combination Product04/15/2020
8NDC:73893-001-0818900 mL in 1 CONTAINER; Type 0: Not a Combination Product04/15/2020
9NDC:73893-001-09113600 mL in 1 DRUM; Type 0: Not a Combination Product04/15/2020
10NDC:73893-001-10189300 mL in 1 DRUM; Type 0: Not a Combination Product04/15/2020
11NDC:73893-001-1159.1 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2020
12NDC:73893-001-12354.9 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
IVOGEL HAND SANITIZER 
antiseptic gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73893-004
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.3 g  in 100 mL
WATER (UNII: 059QF0KO0R) 32.8 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73893-004-0159.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
2NDC:73893-004-02236.6 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
3NDC:73893-004-03473.2 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
4NDC:73893-004-04295.7 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
5NDC:73893-004-05946.4 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
6NDC:73893-004-063800 mL in 1 CONTAINER; Type 0: Not a Combination Product10/23/2020
7NDC:73893-004-079500 mL in 1 CONTAINER; Type 0: Not a Combination Product10/23/2020
8NDC:73893-004-0818900 mL in 1 CONTAINER; Type 0: Not a Combination Product10/23/2020
9NDC:73893-004-09113600 mL in 1 DRUM; Type 0: Not a Combination Product10/23/2020
10NDC:73893-004-10189300 mL in 1 DRUM; Type 0: Not a Combination Product10/23/2020
11NDC:73893-004-1159.1 mL in 1 TUBE; Type 0: Not a Combination Product10/23/2020
12NDC:73893-004-12354.9 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/23/2020
HYDRA PEARL LIQUID 
sanitizing hand spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73893-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18.55 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73893-003-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
2NDC:73893-003-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
3NDC:73893-003-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
4NDC:73893-003-04227304 mL in 1 DRUM; Type 0: Not a Combination Product02/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/09/2020
Labeler - PlasmaDent Inc (053111649)

Revised: 2/2022
Document Id: d8d830bd-b66b-3f7b-e053-2995a90a29ab
Set id: a0fbf042-4f3d-53c3-e053-2a95a90a877b
Version: 15
Effective Time: 20220225
 
PlasmaDent Inc