Label: BENZOIN- benzoin swab
- NDC Code(s): 46414-8888-2
- Packager: James Alexander Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated February 5, 2019
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- Drug Facts
- Active Ingredients (each swab)
Tolu Balsam 4%}Close
Topical bandage adhesiveClose
An adhesive to hold bandages in place.Close
For external use only.
Allergy alert if you have had a history of contact dermatitis with benzoin compounds.
When using this product avoid getting in the wound.
Stop and ask a doctor if a rash develops.
Flammable liquid Keep away from heat, sparks and open flame.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
• Clean and dry skin around the wound. • Gently squeeze vial to crush inner ampoule. • Allow tincture to saturate the tip of the vial, and carefully apply a thin film of the tincture to the skin on each side of the wound. • Allow tincture to dry (30 –40 seconds) before applying bandages.Close
- Other Information
Store at room temperature.Close
- Inactive Ingredients
Call 1-908-362-9266, Monday through Friday, 9:00am – 5:00pm e.s.t.Close
- SPL UNCLASSIFIED SECTION
JAMES ALEXANDER CORPORATION
Blairstown, NJ• (908) 362-9266
Product information and MSDS available on-line at:
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46414-8888 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOIN, (+/-)- (UNII: L7J6A1NE81) (BENZOIN, (+/-) - UNII:L7J6A1NE81) BENZOIN, (+/-)- 0.6 g in 0.6 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE .12 g in 0.6 mL TOLU BALSAM (UNII: TD2LE91MBE) (BALSAM PERU - UNII:8P5F881OCY) TOLU BALSAM .24 g in 0.6 mL LIQUIDAMBAR STYRACIFLUA RESIN (UNII: P41GWD11CX) (LIQUIDAMBAR STYRACIFLUA RESIN - UNII:P41GWD11CX) LIQUIDAMBAR STYRACIFLUA RESIN .48 g in 0.6 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46414-8888-2 60 mL in 1 BOX; Type 0: Not a Combination Product 10/25/1976 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/25/1976 Labeler - James Alexander Corporation (040756421) Registrant - James Alexander Corporation (040756421) Establishment Name Address ID/FEI Business Operations James Alexander Corporation 040756421 manufacture(46414-8888)