Label: HOLY WATER MERCY IN A BOTTLE- lidocaine hcl, benzalkonium chloride solution
- NDC Code(s): 59228-104-18
- Packager: EMS Contract Packaging
- 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 April 22, 2022
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- ACTIVE INGREDIENTS
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
FOR EXTERNAL USE ONLY.
ASK A DOCTOR BEFORE USE IF YOU HAVE A CONDITION THAT COVERS A LARGE AREA OF THE BODY. WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IF CONTACT OCCURS RINSE EYES THOROUGHLY WITH WATER; DISCONTINUE USE IF EXCESSIVE INFLAMMATION OCCURS. IF CONDITION WORSENS OR DOES NOT IMPROVE WITH REGULAR USE AS DIRECTED, CONSULT A PHYSICIAN.
- KEEP OUT OF REACH OF CHILDREN
- CAUTION
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HOLY WATER MERCY IN A BOTTLE
lidocaine hcl, benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59228-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 1000 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EMU OIL (UNII: 344821WD61) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59228-104-18 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/25/2019 Labeler - EMS Contract Packaging (048602791) Establishment Name Address ID/FEI Business Operations EMS Contract Packaging 048602791 manufacture(59228-104)