CLOTRIMAZOLE 1%- clotrimazole cream
Delsam Pharma Llc

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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Clotrimazole Cream USP 1%

DRUG FACTS

ACTIVE INGREDIENT

Clotrimazole USP 1%

PURPOSE

Antifungal

USES

• Cures most 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 the eyes

Stop use and ask a doctor if
• Irritation occurs
• There is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch)

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

DIRECTIONS

• Wash the 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 the 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
• If condition persists longer, consult a doctor
• this product is not effective on the scalp or nails

INACTIVE INGREDIENTS

Sodium Dihydrogen Orthophosphate, White soft paraffin, Sorbitan monostearate, Cetostearyl alcohol, Light liquid paraffin, Propylene glycol, Glycerin, Cetomacrogol -1000, Purified water.

OTHER INFORMATION

• Store at temperature not exceeding 30°C (86°F).
Do not freeze.

QUESTIONS OR COMMENTS?

1-866-826-1306 between 11 am to 4 pm EST, Monday-Friday (or) mail to delsamppharma@yahoo.com

• Relieves Itching & Burning
• Relieves Cracking and Scaling
• Grease less
• Non-Staining

Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543

Packaging

cream-135

CLOTRIMAZOLE 1%
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72570-135
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-20 (UNII: I835H2IHHX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72570-135-09	256 g in 1 CONTAINER; Type 0: Not a Combination Product	08/23/2022	03/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/23/2022	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: 0326a9b1-a63a-4da3-87bf-a5b1b4df1d60

Set id: a4b08b10-6328-4e58-8850-7529673b4124

Version: 2

Effective Time: 20230315

Delsam Pharma Llc