Label: XEPI RUB ET HAND SANITIZING HANDRUB- ethyl alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 81357-101-01, 81357-101-02, 81357-101-03, 81357-101-04, view more81357-101-05, 81357-101-06 - Packager: Sanmed Healthcare Private Limited
- 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 December 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredients
- Purpose
- Uses:
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Warnings:
* For external use only
* Flammable. Keep away from fire or flame, heat sparks and sources of static discharge.
When using this product:
* Keep out of Eyes, Ears and Mouth.
* In case of contact with eyes, rinse promptly & thoroughly with water.
* Discontinue use if irritation and redness develop.
Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.
- Directions:
- Other information:
- Inactive ingredients:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
XEPI RUB ET HAND SANITIZING HANDRUB
ethyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81357-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81357-101-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 2 NDC:81357-101-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 3 NDC:81357-101-03 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 4 NDC:81357-101-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 5 NDC:81357-101-05 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 6 NDC:81357-101-06 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/28/2020 Labeler - Sanmed Healthcare Private Limited (854248431) Establishment Name Address ID/FEI Business Operations Sanmed Healthcare Private Limited 854248431 manufacture(81357-101)