Label: ASSURED BUG BITE RELIEF- sodium bicarbonate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71537-005-01 - Packager: Huijing (Shanghai) Bio-tech Co., Ltd
- 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 12, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASSURED BUG BITE RELIEF
sodium bicarbonate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71537-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71537-005-01 14 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2017 Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337) Establishment Name Address ID/FEI Business Operations Huijing (Shanghai) Bio-tech Co., Ltd 544482337 manufacture(71537-005)