LAMISIL AT CREAM- terbinafine hydrochloride cream

Lamisil AT Cream by

Drug Labeling and Warnings

Lamisil AT Cream by is a Otc medication manufactured, distributed, or labeled by Voyant Beauty Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Terbinafine hydrochloride 1%

Antifungal

Uses

- cure most jock itch (tinea cruris) and ringworm (tinea corporis)

- relieves itching, burning, cracking andf scaling which accompany this condition

Warnings

For external use only

Do not use

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water

Stop use and ask a doctor if too much irritation occurs or gets worse

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

Directions

- adults and children 12 years and over:

• use the tip of the cap to break the seal and open the tube
• wash the affected skin with soap and water and dry completely before applying
• for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
• between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
• on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
• for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
• wash hands after each use

- children under 12 years: ask a doctor

Other Information

- do no use if seal on tube is broken or is not visible

- store at controlled room temperature 20-25C (68-77F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol

Questions or comments?

call 1-800-330-9876

12 g Tube with Carton - For Jock Itch

Lamisil AT

Cream Terbinafine Hydrochloride Cream 1% - Antifungal

For JOCK ITCH

- cures most jock itch

- for effective relief of itching and burning

NET WT

12 g (0.42 oz)

12 g Tube with Carton - For Athlete's Foot

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

Net Wt

12 g (0.42 oz)

30 g Tube with Carton - For Athlete's Foot

Lamisil AT Cream

Terbinafine Hydrochloride Cream 1% - Antifungal

For Athlete's Foot

NET WT

30 g (1 oz)

INGREDIENTS AND APPEARANCE

LAMISIL AT CREAM 
terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61047-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61047-120-01	1 in 1 CARTON	02/24/2020
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 61047-120-02	1 in 1 CARTON	03/02/2020
2		12 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 61047-120-03	1 in 1 CARTON	02/20/2020
3		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
NDA	NDA020980	02/20/2020

Labeler - KIK HOLDCO COMPANY INC. (243547333)

Establishment
Name	Address	ID/FEI	Business Operations
KIK HOLDCO COMPANY INC.		243547333	manufacture(61047-120)