Dosage and administration
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
PROTECTEAV
- Manufacturer
- Camellix, LLC | Inopak, Ltd
- Effective date
- 2020-10-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:13:27
Label at a glance#
ProductPROTECTEAV
Active ingredientALCOHOL
Label structure16 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Contacts and useful links#
Label contents#
Full prescribing information#
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:
- Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Sterile distilled water or boiled cold water.
Active Ingredient(s)
Alcohol 70% 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
- in children less than 2 months of age
- on open skin wounds
OTC - WHEN USING SECTION
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.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
ProtecTeav Hand Sanitizer 2 oz
NDC 54866-321-01
NON-DRYING FORMULA
HAND SANITIZER EC-16
Kills 99.99% Germs
70% Alcohol with EC16*
Aloe Vera
and Vitamin E
Unscented Gently Softens
2 fl oz / 59 mL
Made in USA
U.S. Patents 8076484, 9446017
*EC16 Technology Related Patents
Drug Facts
Active Ingredient Purpose
Ethyl alcohol 70% v/v ……………..Antiseptic
Uses • To decrease bacteria on the skin that potentially can
cause disease. • Recommended for repeated use.
Warnings
• Flammable, keep away from heat or flame.
• For external use only. Keep out of eyes, ears or mouth.
In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away. Children
should be supervised by an adult when using this product.
Other information • Store below 110° F (43° C). • May
discolor certain fabrics or surfaces.
Directions • Apply sufficient amount of product to your
palm to cover both hands. • Rub until dry.
Inactive Ingredients Acrylates /C10-30 alkyl acrylate
crosspolymer, aloe vera barbadensis leaf juice, FD&C
Blue #1, green tea extract, tocopheryl acetate,
triethanolamine, water.
PTV-2 PTV-C-2 Rev. 1.0
protecteav.com
Distributed by ProtecTeaV, LLC Life Sciences Business Development Center Augusta University 1120 15the Street, CA2133 Augusta, GA 30912-7624 |  |
Questions?
888.483.7775 • Monday-Friday 9am-5pm
ProtecTeav Hand sanitizer 8 oz
PROTEC TEAV GREEN TEA TECHNOLOGY
NDC 54866-321-02
NON-DRYING FORMULA
HAND SANITIZER EC-16
Kills 99.99% Germs
70% Alcohol with EC16*
Aloe Vera
and Vitamin E
Unscented Gently Softens
8 fl oz / 236 mL
Made in USA
U.S. Patents 8076484, 9446017
*EC16 Technology Related Patents
Drug Facts
Active Ingredient Purpose
Ethyl alcohol 70% v/v ……………..Antiseptic
Uses • To decrease bacteria on the skin that potentially can
cause disease. • Recommended for repeated use.
Warnings
• Flammable, keep away from heat or flame.
• For external use only. Keep out of eyes, ears or mouth.
In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away. Children
should be supervised by an adult when using this product.
Other information • Store below 110° F (43° C). • May
discolor certain fabrics or surfaces.
Directions • Apply sufficient amount of product to your
palm to cover both hands. • Rub until dry.
Inactive Ingredients Acrylates /C10-30 alkyl acrylate
crosspolymer, aloe vera barbadensis leaf juice, FD&C
Blue #1, green tea extract, tocopheryl acetate,
triethanolamine, water.
PTV-8 PTV-C-8 Rev. 1.0
Distributed by ProtecTeaV, LLC Life Sciences Business Development Center Augusta University 1120 15the Street, CA2133 Augusta, GA 30912-7624 | 888.483.7775 protecteav.com |
|
ProtecTeaV Hand Sanitizer 1000 ml
PROTEC TEAV GREEN TEA TECHNOLOGY
NDC 54866-321-03
NON-DRYING FORMULA
Ingredients:
Acrylates /C10-30 alkyl acrylate
crosspolymer, aloe vera barbadensis leaf juice, FD&C
Blue #1, green tea extract, tocopheryl acetate,
triethanolamine, water.
1000 mL. ProtecTeaV, LLC 888.483.7775 Protecteav.com Do Not Take Internally. Caution: Keep Out of Reach of Children. |
|
ProtecTeaV Hand Sanitizer 1 gal
.PROTEC TEAV GREEN TEA TECHNOLOGY
NDC 54866-321-04
NON-DRYING FORMULA
HAND SANITIZER EC-16
Kills 99.99% Germs
70% Alcohol with EC16*
Aloe Vera
and Vitamin E
Unscented Gently Softens
1 gal / 128 fl oz
Made in USA
U.S. Patents 8076484, 9446017
*EC16 Technology Related Patents
Drug Facts
Active Ingredient Purpose
Ethyl alcohol 70% v/v ……………..Antiseptic
Uses • To decrease bacteria on the skin that potentially can
cause disease. • Recommended for repeated use.
Warnings
• Flammable, keep away from heat or flame.
• For external use only. Keep out of eyes, ears or mouth.
In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away. Children
should be supervised by an adult when using this product.
Other information • Store below 110° F (43° C). • May
discolor certain fabrics or surfaces.
Directions • Apply sufficient amount of product to your
palm to cover both hands. • Rub until dry.
Inactive Ingredients Acrylates /C10-30 alkyl acrylate
crosspolymer, aloe vera barbadensis leaf juice, FD&C
Blue #1, green tea extract, tocopheryl acetate,
triethanolamine, water.
PTV-Gal PTV-C-Gal Rev. 1.0
Distributed by ProtecTeaV, LLC Life Sciences Business Development Center Augusta University 1120 15the Street, CA2133 Augusta, GA 30912-7624 | 888.483.7775 protecteav.com |  |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54866-321-01 | 2020-10-02 | C162847 | 48780-1 | 9d75b9d0-6136-f424-e053-dadaa90a57ce | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee |
| 54866-321-02 | 2020-10-02 | C162847 | 48780-1 | 9d75b9d0-6136-f424-e053-dadaa90a57ce | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee |
| 54866-321-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6136-f424-e053-dadaa90a57ce | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee |
| 54866-321-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6136-f424-e053-dadaa90a57ce | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee |
Products#
Every source-derived product name is available through these pages.
- PROTECTEAV
- Alcohol
- WATER
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54866-321 | 54866-321-02, 54866-321-01, 54866-321-03, 54866-321-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d1f4b7a8-61e7-6c70-e053-2995a90a9cd4 | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee | 2021-11-29 | Warnings | 443cd11b-fa69-4532-9c1d-1a8919a4c1ee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.