Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79078-002-01, 79078-002-02, 79078-002-03, 79078-002-04, view more79078-002-05, 79078-002-06, 79078-002-07, 79078-002-08, 79078-002-09, 79078-002-10 - Packager: Articulos Medicos Brooks, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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Package Label - Principal Display Panel
PDP 60 mL NDC: 79078-002-01
PI 60 mL NDC: 79078-002-01
PDP 236.58 mL NDC: 79078-002-02
PI 236.58 mL NDC: 79078-002-02
PDP 250 mL NDC: 79078-002-03
PI 250 mL NDC: 79078-002-03
PDP 473.1 mL NDC: 79078-002-04
PDP 500 mL NDC: 79078-002-05
PDP 1000 mL NDC: 79078-002-06
PDP 3785 mL NDC: 79078-002-07
PDP 5000 mL NDC: 79078-002-08
PDP 200000 mL NDC: 79078-002-09
PDP 1000000 mL NDC: 79078-002-10
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79078-002 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 GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL in 100 mL TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 0.3 mL in 100 mL WATER (UNII: 059QF0KO0R) CARBOMER 1342 (UNII: 809Y72KV36) 0.49 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79078-002-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:79078-002-02 236.58 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:79078-002-03 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:79078-002-04 473.1 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:79078-002-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:79078-002-06 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 7 NDC:79078-002-07 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 8 NDC:79078-002-08 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 9 NDC:79078-002-09 200000 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 10 NDC:79078-002-10 1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Articulos Medicos Brooks, S.A. de C.V. (951579414) Establishment Name Address ID/FEI Business Operations Articulos Medicos Brooks, S.A. de C.V. 951579414 manufacture(79078-002) , pack(79078-002) , label(79078-002)