NEWGEL PLUS SPF- zinc oxide, sunscreen gel BRUISE MD- allantoin gel

Bruise MD by

Drug Labeling and Warnings

Bruise MD by is a Otc medication manufactured, distributed, or labeled by Newmedical Technology, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

INACTIVE INGREDIENT

WARNINGS

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEWGEL PLUS SPF 
zinc oxide, sunscreen gel

Product 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 gel

Product 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
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)
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)

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)