MOLECULAR AF MOLECULAR CREAM- molecular af molecular cream cream 
Renu Laboratories, Inc.

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.

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Molecular AF Molecular Cream

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this product avoid contact with the eyes

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control

Center right away

Directions

Directions:

Other Information

Inactive Ingredients

Cetearyl Alcohol, Ceteareth-20, Cinnamonum Verum Oil, Citric Acid, Deionized Water, Emulsifying Wax NF, Ethyl Macadamiate,

Glycerin (Veg.), Melaleuca Alternifolia Oil, Olea Europaea Oil, Origanum Vulgare Oil, Phenoxyethanol, Benzoic Acid,

Dehydroacetic Acid, Propylene Glycol, Trimethylpentanediol / Adipic Acid Copolymer, Vitamin E Acetate, Xanthan Gum

Directions:

Molecular AF Tube art

BOX, Principal Display Panel

Single Unit Box

MOLECULAR AF MOLECULAR CREAM 
molecular af molecular cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate0.3 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Glycerin (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
TRIMETHYL-1,3-PENTANEDIOL (UNII: WT1X081P0L)  
Tea Tree Oil (UNII: VIF565UC2G)  
Cinnamon Oil (UNII: E5GY4I6YCZ)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
TROLAMINE (UNII: 9O3K93S3TK)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Oregano Leaf Oil (UNII: 7D0CGR40U1)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Olive Oil (UNII: 6UYK2W1W1E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
Colorwhite (Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-402-021 in 1 BOX03/31/2015
1NDC:76348-402-0114 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/31/2015
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-402)

Revised: 1/2022
Document Id: d5c9e15b-7e83-d9a5-e053-2995a90a9725
Set id: 0fdc69e0-bb02-5de4-e054-00144ff8d46c
Version: 14
Effective Time: 20220117
 
Renu Laboratories, Inc.