EYEFULL PCD KIT- alcohol
Rafac International 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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Eyefull PCD Kit (Green)
Active ingredients
Ethyl Alcohol 75%
Uses
- Hand sanitizer to help reduce bacteria that potentially cause disease.
- For use when soap and water are not available
Warnings
For external use only. Flammable. Keep away from heat or flame.
Stop use and ask a doctor if
irritation or rash occurs. These may be signs of a serious condition.
Do not use
- On children of less than 5 year of age.
- On open skin wounds.
When using this product
keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.
- Discard in trash receptacle after use.
- Do not flush.
Other information
- Store in cool,dry place, between 15°-30°C(59°F-86°F).
- Avoid freezing and excessive heat above 40°C(104°F).
Inactive ingredients
Purified water USP
Package Labeling:80184-999-10
Package Labeling:
80184-996-10
Kit Outer Package
EYEFULL PCD KIT
alcohol kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 80184-997 |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 80184-997-15 | 1 in 1 KIT | 08/29/2020 | 08/29/2020 |
|
| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 1 BOTTLE | 100 mL |
| Part 2 | 1 PATCH | 3.5 mL |
|
| Part 1 of 2 |
EYEFULL HAND SANITIZER
alcohol gel |
|
| Product Information |
| Item Code (Source) | NDC: 80184-999 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 0.75 mL in 1 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 80184-999-11 | 100 mL in 1 BOTTLE; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 08/29/2020 | 08/29/2020 |
|
| Part 2 of 2 |
EYEFULL DISINFECTANT WET WIPES
alcohol cloth |
|
| Product Information |
| Item Code (Source) | NDC: 80184-996 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 0.75 mL in 1 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 80184-996-11 | 20 in 1 BAG | | |
| 1 | | 3.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 08/29/2020 | 08/29/2020 |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 08/29/2020 | 08/29/2020 |
|
| Labeler - Rafac International Inc
(940392103)
|