Label: OSEQUE SAFETY HAND WET WIPES- benzalkonium chloride cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 59370-150-01 - Packager: SONGHAK CO., 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 July 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
-
WARNINGS
For external use only
--------------------------------------------------------------------------------------------------------
Do not use
■ on infants
■ on open skin wounds
--------------------------------------------------------------------------------------------------------
When using this product
■ avoid getting into the eyes
■ In case of eye contact immediately flush eyes thoroughly with water
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor
■ if irritation or redness develops
■ conditions persist for more than 72 hours
■ redness is present - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OSEQUE SAFETY HAND WET WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59370-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.1 in 100 Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Sodium Benzoate (UNII: OJ245FE5EU) Polysorbate 20 (UNII: 7T1F30V5YH) Ethylhexylglycerin (UNII: 147D247K3P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59370-150-01 20 in 1 PACKET; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/01/2020 Labeler - SONGHAK CO., LTD. (688237512) Registrant - SONGHAK CO., LTD. (688237512) Establishment Name Address ID/FEI Business Operations NAICO 694725335 manufacture(59370-150)