TINA DAVIES ICECREAM- lidocaine hydrochloride, phenylephrine hydrochloride cream

Tina Davies IceCream by

Drug Labeling and Warnings

Tina Davies IceCream by is a Otc medication manufactured, distributed, or labeled by TINA DAVIES PROFESSIONAL LLC, THE SKINCARE FOUNDRY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Lidocaine HCl 5%

Phenylephrine HCl 0.25%

Purpose

Local anesthetic

Vasoconstrictor

Uses

 For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
For temporary relief of pain.

Warnings

For external use only
Allergy alert:
Certain persons can develop allergic reactions to ingredients in this product. The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Ask a doctor before use if
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland.
Ask a doctor or pharmacist before use if you
are presently taking a prescription drug for high blood pressure or depression.
When using this product
do not exceed the recommended daily 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
Condition worsens or does not improve within 7 days.
Bleeding occurs.

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

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply externally to the affected area up to 4 times daily.
Children under 12 years of age: consult a doctor.

Inactive ingredients

Acetyl Hexapeptide-8, Butylene Glycol, Carboxymethyl Cellulose 2500, Chloroxylenol, Hexanediol CG, Pentapeptide-18, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

SPL UNCLASSIFIED SECTION

2-in-1 Maximum

Strength Formula

Hemorrhoidal cream

with vasoconstrictor

and local anesthetic

Manufactured for Tina Davies Professional LLC

1020 Holland Drive, Unit

109 Boca Raton, FL 33487

1-888-510-1388

tinadavies.com

Packaging

INGREDIENTS AND APPEARANCE

TINA DAVIES ICECREAM 
lidocaine hydrochloride, phenylephrine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84313-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
HEXANEDIOL (UNII: ZIA319275I)
PENTAPEPTIDE-18 (UNII: PO4D55T1IG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84313-001-30	1 in 1 CARTON	06/12/2024
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84313-001-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	06/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	06/12/2024

Labeler - TINA DAVIES PROFESSIONAL LLC (119265327)

Establishment
Name	Address	ID/FEI	Business Operations
THE SKINCARE FOUNDRY LTD		230986608	manufacture(84313-001)