Label: SOPURE- denatured ethanol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 80773-002-01, 80773-002-02, 80773-002-03, 80773-002-04 - Packager: EnviroServe Chemicals & Cleaners Ltd
- 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 November 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Warnings
- Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.
- If irritation develops, consult a doctor. Keep out of reach of children.
- Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician).
- Ifswallowed, call a poison control center or get medical help right away.
- Keep away from open flame and sources of heat.
- Uses
- Directions
- Keep out of reach of Children
- Inactive Ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
SOPURE
denatured ethanol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80773-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.8 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROGEN PEROXIDE (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80773-002-01 100 in 1 POUCH; Type 0: Not a Combination Product 11/23/2021 2 NDC:80773-002-02 80 in 1 POUCH; Type 0: Not a Combination Product 11/23/2021 3 NDC:80773-002-03 120 in 1 POUCH; Type 0: Not a Combination Product 11/23/2021 4 NDC:80773-002-04 160 in 1 POUCH; Type 0: Not a Combination Product 11/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/23/2021 Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)
