FORMULA 2 SKIN CARE- lidocaine 5% cream

Formula 2 Skin Care by

Drug Labeling and Warnings

Formula 2 Skin Care by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, Derrma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5.0%

PURPOSE

Local Anesthetic

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS

For external use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
• Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: consult a doctor.
• To use finger cots: roll one finger cot over a finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area

INACTIVE INGREDIENT

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORMULA 2 SKIN CARE 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-265-00	28 g in 1 TUBE; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/09/2020

Labeler - Derma Care Research Labs (116817470)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derrma Care Research Labs		116817470	manufacture(72839-265)