Label: BURN TREATMENT- benzalkonium chloride, lidocaine hydrochloride cream
- NDC Code(s): 49687-0014-0
- Packager: CMC Group Inc.
- 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.
Updated January 7, 2021
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- Drug Facts
- Active ingredients
For external use only.
Do not use
• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor
Stop use and ask a doctor if
• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
benzalkonium chloride, lidocaine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49687-0014 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 GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49687-0014-0 10 in 1 KIT 08/06/2016 1 0.9 g in 1 POUCH; 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 08/06/2016 Labeler - CMC Group Inc. (117201448)