Label: NEWGEL PLUS SPF- zinc oxide, sunscreen gel
BRUISE MD- allantoin gel
- NDC Code(s): 69291-8050-2, 69291-9020-1, 69291-9020-2
- Packager: Newmedical Technology, Inc.
- 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 June 8, 2023
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- Official Label (Printer Friendly)
- PURPOSE
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NEWGEL PLUS SPF
zinc oxide, sunscreen gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69291-8050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69291-8050-2 15 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 10/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/01/2016 BRUISE MD
allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69291-9020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.55 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BROMELAINS (UNII: U182GP2CF3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ASCORBIC ACID (UNII: PQ6CK8PD0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLUCOSYL HESPERIDIN (UNII: 432C95B6YE) CARBOMER 940 (UNII: 4Q93RCW27E) VITIS VINIFERA SEED (UNII: C34U15ICXA) WATER (UNII: 059QF0KO0R) ARNICA MONTANA (UNII: O80TY208ZW) SODIUM LACTATE (UNII: TU7HW0W0QT) .ALPHA.N-(METHOXYCARBONYL)-L-ARGININE (UNII: PE4EFA9P6E) PHYTONADIONE (UNII: A034SE7857) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69291-9020-1 1 in 1 CARTON 12/02/2019 1 NDC:69291-9020-2 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/20/2019 Labeler - Newmedical Technology, Inc. (787828669) Registrant - Newmedical Technology, Inc. (787828669) Establishment Name Address ID/FEI Business Operations Newmedical Technology, Inc. 787828669 manufacture(69291-8050, 69291-9020)
