ALCOHOL BASED HAND SANITIZER TOTAL PURE- hand sanitizer gel
CALIDAD Y SERVICIO VIAN 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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TOTAL PURE BY CYS VIAN
KEEP OUT OF REACH SECTION
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Active ingedient.
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PURPOSE
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WARININGS AND PRECAUTIONS
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DOSAGE AND ADMINISTRATION
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INDICATIONS AND USAGE SECTION
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WARNINGS
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INACTIVE INGREDIENTS
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500 ml FRONT DISPLAY
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1000 ml FRONT LABEL DISPLAY
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ALCOHOL BASED HAND SANITIZER TOTAL PURE
hand sanitizer gel |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 79787-002 |
Route of Administration | TOPICAL |
|
Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 70 mL in 100 mL |
|
Inactive Ingredients |
Ingredient Name | Strength |
CARBOMER 940 (UNII: 4Q93RCW27E) | 0.25 mL in 100 mL |
TROLAMINE (UNII: 9O3K93S3TK) | 0.25 mL in 100 mL |
WATER (UNII: 059QF0KO0R) | 29.3 mL in 100 mL |
GLYCERIN (UNII: PDC6A3C0OX) | 0.2 mL in 100 mL |
|
Product Characteristics |
Color | white (COLORLESS) | Score | |
Shape | | Size | |
Flavor | | Imprint Code | |
Contains | |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 79787-002-01 | 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product | 05/29/2020 | |
2 | NDC: 79787-002-02 | 500 mL in 1 BOTTLE; Type 0: Not a Combination Product | 05/29/2020 | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part333E | 05/29/2020 | 09/17/2020 |
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Labeler - CALIDAD Y SERVICIO VIAN S.A DE C.V.
(951578030)
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Registrant - CALIDAD Y SERVICIO VIAN S.A. DE C.V. (951578030) |
Establishment |
Name | Address | ID/FEI | Business Operations |
CALIDAD Y SERVICIO VIAN S.A. DE C.V. | | 951578030 | manufacture(79787-002) |