S-Cream TOLNAFTATE 1% ANTIFUNGAL CREAM

S-Cream TOLNAFTATE 1% by

Drug Labeling and Warnings

S-Cream TOLNAFTATE 1% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

S-CREAM TOLNAFTATE 1%- tolnaftate cream 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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S-Cream TOLNAFTATE 1% ANTIFUNGAL CREAM

Drug Facts

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

INACTIVE INGREDIENTS

Disteardimonium hectorite, Fragrance, Isobutane, Isopropyl myristate, SD alcohol 40-B, Sodium bicarbonate.

USES

Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)  If used daily, can prevent recurrence of athlete's foot  Relieves symptoms of athlete's foot, including itching, burning and cracking.

WARNINGS

For external use only

Flammable:
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

When using this product
Do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water 
 Use only as directed 
 Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Stop use and ask a doctor if
Irritation occurs
No improvement within 4 weeks

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

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

DIRECTIONS

Wash affected area and dry thoroughly

Spray 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Use daily for 4 weeks; if conditions persist, consult a doctor.

Apply once or twice daily (morning and/or night).

OTHER INFORMATION

Store between 20° and 30°C (68°F and 86°).

Questions or comments?

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

ANTIFUNGAL CREAM

Manufactured by :

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-CREAM TOLNAFTATE 1% 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-011-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 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	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-011)

Revised: 2/2023

Document Id: f42b730c-51d5-028c-e053-2995a90af170

34390-5

Set id: 967545f0-8bd3-4f23-bd91-db49436cdf75

Version: 2

Effective Time: 20230208