GROMEDI 5X- minoxidil 5% spray

Gromedi 5x by

Drug Labeling and Warnings

Gromedi 5x by is a Otc medication manufactured, distributed, or labeled by Orange Lab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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DO NOT USE IF

Maybe be harmful if used when pregnant or breast-feeding.

When using this product

Inactive ingredient

Directions

Do not use on children

Directions for dosage / frequency

Dosage and Administration

Warnings section

Indications and usage

Keep out of reach of children

Purpose

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INGREDIENTS AND APPEARANCE

GROMEDI 5X 
minoxidil 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71331-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
APIGENIN (UNII: 7V515PI7F6)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
SAW PALMETTO (UNII: J7WWH9M8QS)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
URTICA DIOICA ROOT (UNII: J8HE8A6E5T)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE SODIUM (UNII: MP1J8420LU)
PANTHENOL (UNII: WV9CM0O67Z)
BIOTIN (UNII: 6SO6U10H04)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BEE PROPOLIS EXTRACT (UNII: 6Y8XYV2NOF)
PAULLINIA CUPANA SEED (UNII: C21GE7524R)
ASIAN GINSENG (UNII: CUQ3A77YXI)
MENTHOL (UNII: L7T10EIP3A)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71331-104-04	118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/22/2018

Labeler - Orange Lab (004862271)

Registrant - Orange Lab (004862271)

Establishment
Name	Address	ID/FEI	Business Operations
Orange Lab		004862271	manufacture(71331-104)