Label: WOUND AND BURN CARE REFILL PACK- benzalkonium chloride, lidocaine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0040-1, 69842-401-00 - Packager: CVS
- 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 December 28, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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PRINCIPAL DISPLAY PANEL
Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
Genuine First AidGFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com -
INGREDIENTS AND APPEARANCE
WOUND AND BURN CARE REFILL PACK
benzalkonium chloride, lidocaine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-401 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-401-00 1 in 1 BAG; Type 0: Not a Combination Product 12/01/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PACKET 2 g in .9 Part 1 of 1 GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine creamProduct Information Item Code (Source) NDC:52124-0040 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 ANHYDROUS 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0040-1 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333A 12/01/2016 Labeler - CVS (062312574) Establishment Name Address ID/FEI Business Operations Tender Corporation 064437304 manufacture(69842-401)