CLOTRIMAZOLE by ACINO PRODUCTS LIMITED LIABILITY COMPANY CLOTRIMAZOLE solution

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by ACINO PRODUCTS LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CLOTRIMAZOLE USP, 1%

PURPOSE

ANTIFUNGAL

USES

Cures most

Athlete's foot (tinea pedis)
Jock Itch (tinea cruris)
Ringworm (tinea corporis)

Effectively relieves
Itching
Cracking
Burning
Discomfort which can accompany these conditions
This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
clean the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
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; change shoes and socks at least once daily.

WARNINGS

For external use only
Ask a doctor before use on children under 2 years of age
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 and ringworm) or 2 weeks (for jock itch)

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• 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; change shoes and socks at least once daily.

OTHER INFORMATION

Store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

polyethylene glycol 400

QUESTIONS

call 1-877-227-2594

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68784-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68784-301-10	1 in 1 BOX	07/29/2019
1	NDC: 68784-301-01	10 mL in 1 BOTTLE; 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	07/29/2019

Labeler - ACINO PRODUCTS LIMITED LIABILITY COMPANY (019385518)

Establishment
Name	Address	ID/FEI	Business Operations
ACINO PRODUCTS LIMITED LIABILITY COMPANY		019385518	manufacture(68784-301)