S-Cream CLOTRIMAZOLE CREAM 1% ANTI-FUNGAL

S-Cream CLOTRIMAZOLE Cream 1% by

Drug Labeling and Warnings

S-Cream CLOTRIMAZOLE Cream 1% 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 CLOTRIMAZOLE CREAM 1%- clotrimazole 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 CLOTRIMAZOLE CREAM 1% ANTI-FUNGAL

Drug Facts

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

INACTIVE INGREDIENTS

Benzyl alcohol (1%), Cetostearyl alcohol, Cetyl esters wax, 2-Octyldodecanol, Polysorbate 60, Purified water, Sorbitan monostearate

USES

Athlete's foot, jock itch and Ringworm, Relieves itching, burning, cracking, scaling and discomfort which 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; There is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

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

DIRECTIONS

Wash affected area and dry thoroughly

Apply a thin layer over affected area twice daily (morning and night)

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 socks at least once daily

For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks

If condition persists longer, seek medical advice

This product is not effective on the scalp or nails

OTHER INFORMATION

To open: unscrew cap, use the pointed end of cap to puncture seal.

Store between 20° - 25°C (68° - 77°F)

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

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-CREAM CLOTRIMAZOLE CREAM 1% 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-014-30	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(73921-014)

Revised: 2/2023

Document Id: f42b2336-f91f-6394-e053-2a95a90ac573

34390-5

Set id: 1c3140c4-e27a-42bc-86a1-196e0a0d364c

Version: 2

Effective Time: 20230208