Label: NORTH WOODS DERMA FOAM E-2- benzalkonium chloride soap
- NDC Code(s): 53125-817-29
- Packager: Superior Chemical Corporation
- 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 29, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
- For external use only.
- When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
- Stop use and ask a doctor If irritation persists or redness deelops, or if condition persists for more than 72 hours.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Superior Derma Foam E2
- Superior Derma Foam E2
- Superior Derma Foam E2
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INGREDIENTS AND APPEARANCE
NORTH WOODS DERMA FOAM E-2
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53125-817 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53125-817-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 09/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2016 Labeler - Superior Chemical Corporation (023335086) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(53125-817) , label(53125-817) , pack(53125-817)
