REXALL ATHLETES FOOT- clotrimazole cream

Rexall Athletes Foot by

Drug Labeling and Warnings

Rexall Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Dollar General, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling and discomfort

Warnings

For external use only.

Avoid contact with eyes.

Do not use on children under 2 years of age unless directed by a doctor.

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• 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

• store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

1-866-4-REXALL

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

Since 1903
Rexall®

Athlete's Foot
Antifungal Cream

Contains the drug clotrimazole
NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

REXALL ATHLETES FOOT 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	0.01 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
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: 55910-340-24	1 in 1 CARTON	10/01/2017
1		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	10/01/2017

Labeler - Dollar General (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(55910-340)