Label: SANICLEAN ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION GEL, UNSCENTED (HP2463)- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58039-102-01, 58039-102-02, 58039-102-03, 58039-102-04, view more58039-102-05, 58039-102-06 - Packager: HPPE LLC
- 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 July 6, 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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SANICLEAN ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION GEL, UNSCENTED (HP2463)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58039-102 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 GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58039-102-01 1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product 04/22/2020 2 NDC:58039-102-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 3 NDC:58039-102-03 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 4 NDC:58039-102-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 5 NDC:58039-102-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 6 NDC:58039-102-06 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/22/2020 Labeler - HPPE LLC (078769356) Establishment Name Address ID/FEI Business Operations HPPE, LLC 078769356 manufacture(58039-102)