GROMEDI 5X- minoxidil 5% spray 
Orange Lab

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Gromedi 5x Topical Spray

Active Ingredient

Active ingredient

Ask a doctor

Ask a doc

DO NOT USE IF

Do not use if

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

Pregnant or breast feeding

When using this product

when using this product

Inactive ingredient

Inactive Ingredient

Directions

Directions

Do not use on children

do not use on children

Directions for dosage / frequency

dosage

Dosage and Administration

dosage

Warnings section

warnings

Indications and usage

indication

Keep out of reach of children

Keep out of reach of children

Purpose

purpose

Front display panel

front panel image

GROMEDI 5X 
minoxidil 5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71331-104-04118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/22/2018
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab004862271manufacture(71331-104)

Revised: 10/2018
Document Id: 7731faec-a8d4-4458-e053-2991aa0aa1f7
Set id: 741edbef-828c-7a86-e053-2a91aa0a76fb
Version: 3
Effective Time: 20181001
 
Orange Lab