Label: GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE- benzalkonium chloride, lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0004-1, 52124-0004-2, 52124-0004-3 - Packager: Genuine First Aid
- 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.
Drug Label Information
Updated April 25, 2012
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- Active Ingredients
- Purpose
- Uses
- Warnings
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DO NOT USE
Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week
Do not use:
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
in large quantities, particularly over raw surfaces or blistered areas.
Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
When using this product, avoid contact with the eyes.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- STORAGE AND HANDLING
- Inactive Ingredients
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0004-1 0.9 g in 1 PACKET 2 NDC:52124-0004-2 6 in 1 BOX 2 0.9 g in 1 PACKET 3 NDC:52124-0004-3 100 in 1 CARTON 3 0.9 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333A 04/23/2010 Labeler - Genuine First Aid (619609857)
