GSD ANTI BACTERIAL- alcohol gel
Good Spirits Distilling, LLC
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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GSD Anti-Bacterial Gel
Active ingredient[s]
Ethyl Alcohol 73.30% v/v
Use[s]
- 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
- on children less than 2 months 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.
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
- 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
- Hydroxypropylcellulose, Aqua (water), Lauryl Lactate and MyristylLactate and cetylLactate, Glycerin, Lemongrass Essential Oil
Package Labeling: 1750ml
Package Labeling: 1000ml
Package Labeling: 750ml
Package Labeling: 500ml
Package Labeling: 375ml
Package Labeling: 250ml
Package Labeling: 100ml
GSD ANTI BACTERIAL
alcohol gel |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 78631-000 |
| Route of Administration | TOPICAL |
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| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 0.733 mL in 1 mL |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 78631-000-06 | 1750 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 2 | NDC: 78631-000-05 | 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 3 | NDC: 78631-000-04 | 750 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 4 | NDC: 78631-000-03 | 500 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 5 | NDC: 78631-000-02 | 375 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 6 | NDC: 78631-000-01 | 250 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
| 7 | NDC: 78631-000-00 | 100 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/20/2020 | 06/01/2022 |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 06/20/2020 | 06/01/2022 |
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| Labeler - Good Spirits Distilling, LLC
(005269281)
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