Label: DG HEALTH- benzalkonium, lidocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 72667-006-01 - Packager: Inspec Solutions LLC.
- 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.
Drug Label Information
Updated June 17, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WHEN USING
- PURPOSE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
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WARNINGS
WARNINGS
For external use only.
When using this product:
do not use in or near the eye
do not apply over large areas of the body or in large quantities
do not apply over raw surface or blistered areas
Stop use and ask a doctor if
condition worsens
symptoms presist for over than 7 days, or clear up and occur sgain within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DG HEALTH
benzalkonium, lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-006 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 mL LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) NONOXYNOL-9 (UNII: 48Q180SH9T) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-006-01 148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2019 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-006)
