Label: CAREALL MICONAZOLE NITRATE- miconazole nitrate cream
- NDC Code(s): 51824-078-01
- Packager: New World Imports, 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.
Updated December 1, 2020
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- Active Ingredient
- Keep out of Reach of Children
For external use only.
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoide contact with eyes
Stop use and ask doctor if
- irritation occurs
- condition persists
- there is no improvement of athlete's foot or ringworm within 4 weeks and jock itch within 2 weeks
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot, pay special attention to spaces between the toes, wear well fitting, ventilated shoes and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks
- for jock itch, use daily for 2 weeks
- not effective on the scalp or nails
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CAREALL MICONAZOLE NITRATE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-078-01 28 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/01/2020 Labeler - New World Imports, Inc (075372276)