Label: RUGBY ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 0536-1272-11, 0536-1272-22
- Packager: RUGBY
- 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 February 12, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only.
Avoid contact with eyes.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in 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
- if condition persists longer, consult a doctor
- this product is not effective on scalp or nails
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
INGREDIENTS AND APPEARANCE
RUGBY ANTIFUNGAL CLOTRIMAZOLE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1272 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CETYL ALCOHOL (UNII: 936JST6JCN) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1272-22 1 in 1 CARTON 01/14/2020 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0536-1272-11 1 in 1 CARTON 01/14/2020 2 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 01/14/2020 Labeler - RUGBY (079246066) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(0536-1272)