S-Cream MICONAZOLE NITRATE USP 2% ANTIFUNGAL CREAM

S-Cream MICONAZOLE NITRATE 2% by

Drug Labeling and Warnings

S-Cream MICONAZOLE NITRATE 2% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

S-CREAM MICONAZOLE NITRATE 2%- miconazole nitrate cream 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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S-Cream MICONAZOLE NITRATE USP 2% ANTIFUNGAL CREAM

Drug Facts

ACTIVE INGREDIENT

Miconazole Nitrate USP 2%

PURPOSE 

Antifungal

INACTIVE INGREDIENTS

Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Microcrystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

USES

Effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

 For effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

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 eyes.

Stop use and ask a doctor if
Irritation occurs Condition persists  There is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

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

DIRECTIONS

 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

OTHER INFORMATION

Do not use if seal is damaged or is not visible  To open, unscrew cap, pull tab to remove foil seal  store at temperature not exceeding 30°C (86°F). Do not freeze.  see carton or tube crimp for lot number and expiration date

Questions or comments?

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

ANTI-FUNGAL CREAM

Manufactured by :

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-CREAM MICONAZOLE NITRATE 2% 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CHLOROCRESOL (UNII: 36W53O7109)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-012-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 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	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-012)

Revised: 2/2023

Document Id: f42ad874-1134-1ea4-e053-2995a90a9e03

34390-5

Set id: 19a481b9-aa37-423d-99b1-53c5e2c7091b

Version: 2

Effective Time: 20230208