Label: HAND SANITIZING- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77110-600-01, 77110-600-02, 77110-600-03, 77110-600-04 - Packager: Biominerales Pharma
- 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 September 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Inactive ingredients
- Use (s)
- Directions
- Other information
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Cautions and warnings
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- For external use only
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- Flammable
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- Keep away from heat or flame
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- Keep out of reach of children
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- When using this product keep our of eyes, ears and mouth.
In case of contact with eyes, rinse eyes thoroughly with water
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- These may be signs of a serious condition
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 473 mL Container Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZING
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77110-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC) Propylene Glycol (UNII: 6DC9Q167V3) Trolamine (UNII: 9O3K93S3TK) Hydrogen Peroxide (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77110-600-04 236 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/01/2020 2 NDC:77110-600-03 473 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/01/2020 3 NDC:77110-600-02 946 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/01/2020 4 NDC:77110-600-01 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 09/01/2020 Labeler - Biominerales Pharma (117489663) Establishment Name Address ID/FEI Business Operations Biominerales Pharma 117489663 MANUFACTURE(77110-600)