Label: BENZALKONIUM CHLORIDE ANTISEPTIC - benzalkonium chloride swab
- NDC Code(s): 35617-393-01
- Packager: NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated May 26, 2010
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- Active Ingredients
Benzalkonium Chloride 0.4%
Prevent infection in minor scrapes
For external use only
Flammable,keep away for fire or flame
Do not use:
* In large quantities
* over large areas of the body
* in eyes
* over raw or blistered areas
Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.
Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
Children under 2 years of age ; Consult a doctor
- Inactive Ingredient
- INGREDIENTS AND APPEARANCE
BENZALKONIUM CHLORIDE ANTISEPTIC
benzalkonium chloride swab
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35617-393 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.004 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35617-393-01 1 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 05/20/2010 Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519) Establishment Name Address ID/FEI Business Operations NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519 manufacture