Label: COROCCLEAN HAND SANITIZER- isopropyl alcohol liquid
COROCLEAN HAND SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78925-001-10, 78925-001-20, 78925-002-10, 78925-002-20 - Packager: Rhydburg Pharmaceuticals Limited
- Category: HUMAN OTC DRUG LABEL
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 January 8, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)
- Isopropyl Alcohol (70%, v/v)
- Glycerol (0.5% v/v).
- Propylene Glycol (1% v/v).
- Carbomer 940 (0.20% v/v)
- SodiumHydroxide (0.015% v/v)
- Lemongrass Oil ( INHS) (0.10% v/v)
- Purified water q. s. to 1 ml
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- 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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
COROCCLEAN HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78925-001 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 GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78925-001-10 100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/30/2020 2 NDC:78925-001-20 200 mL in 1 BOTTLE, DISPENSING; 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 COROCLEAN HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78925-002 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 GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78925-002-10 100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/30/2020 2 NDC:78925-002-20 200 mL in 1 BOTTLE, DISPENSING; 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 - Rhydburg Pharmaceuticals Limited (650552128) Establishment Name Address ID/FEI Business Operations Rhydburg Pharmaceuticals Limited 650552128 manufacture(78925-001, 78925-002)