Rexall Jock Itch (Clotrimazole) Cream [Dollar General] -

REXALL JOCK ITCH (CLOTRIMAZOLE) CREAM [DOLLAR GENERAL]
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NDC	55910-343-24
Set ID	11427a79-f262-4702-9b2e-ec1955a9b2da
Category	HUMAN OTC DRUG LABEL
Packager	Dollar General
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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®

Jock Itch
Clotrimazole Cream

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

REXALL JOCK ITCH
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-343
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55910-343-24	1 in 1 CARTON	10/01/2017
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	10/01/2017

Labeler - Dollar General (068331990)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(55910-343)

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Medic

REXALL JOCK ITCH (CLOTRIMAZOLE) CREAM [DOLLAR GENERAL]

Stop use and ask a doctor if

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