HAND SANITIZER- alcohol gel
BIOTECNOLOGIA EDUCACION Y GENETICA S.A.DE.C.V
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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Hand Sanitizer
Active ingredient
Ethyl Alcohol 70% v/v
Uses
- Hand sanitizer to decrease bacteria on the skin.
- Recommended for repeated use.
Warnings
For external use only
- Flammable
- Keep away from fire or flame
When using this product:
- Do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor
- If irritation and redness persist for more than 72 hours.
Keep out of reach of children.
In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
Directions
- Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry.
- Children under six years of age should be supervised when using this product.
Other Information
- Store at 1°C-30°C (34°F-86°F)
Inactive Ingreidients
Carbomer, Glycerin, Triethanolamine, Water.
Package Labeling:1000ml
Package Labeling:3780ml
Package Labeling:500ml
Package Labeling:250ml
HAND SANITIZER
alcohol gel |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 79840-001 |
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 | 0.7 mL in 1 mL |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 79840-001-01 | 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/01/2020 | 11/01/2020 |
2 | NDC: 79840-001-02 | 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/01/2020 | 11/01/2020 |
3 | NDC: 79840-001-03 | 500 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/01/2020 | 11/01/2020 |
4 | NDC: 79840-001-04 | 250 mL in 1 BOTTLE; Type 0: Not a Combination Product | 06/01/2020 | 11/01/2020 |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part333E | 06/01/2020 | 11/01/2020 |
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Labeler - BIOTECNOLOGIA EDUCACION Y GENETICA S.A.DE.C.V
(951580322)
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BIOTE
Trademark Results [Hand Sanitizer]