Label: MOLECULAR AF MOLECULAR CREAM cream
- NDC Code(s): 76348-402-01, 76348-402-02
- Packager: Renu Laboratories, 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 January 17, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
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
- irritation occurs
- there is no improvement with 4 weeks
- KEEP OUT OF REACH OF CHILDREN
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Directions
Directions:
- clean the affected area and dry thoroughly
- apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and
change shoes and socks at least once daily. - use daily for 4 weeks. If condition lasts longer, ask a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not effective on the scalp or nails
- Other Information
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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
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DOSAGE & ADMINISTRATION
Directions:
- clean the affected area and dry thoroughly
- apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to the spaces between toes..
Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily - use daily for 4 weeks. If condition lasts longer, as a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not effective on the scalp or nails
- PRINCIPAL DISPLAY PANEL
- BOX, Principal Display Panel
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INGREDIENTS AND APPEARANCE
MOLECULAR AF MOLECULAR CREAM
molecular af molecular cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 0.3 g in 14 g Inactive Ingredients Ingredient Name Strength 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 Color white (Cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-402-02 1 in 1 BOX 03/31/2015 1 NDC:76348-402-01 14 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 part333C 03/31/2015 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-402)
