TINA DAVIES ICECREAM- lidocaine hydrochloride, phenylephrine hydrochloride cream 
TINA DAVIES PROFESSIONAL LLC

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tina davies IceCream

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).

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

Tina Davies IceCreamTina Davies IceCream

TINA DAVIES ICECREAM 
lidocaine hydrochloride, phenylephrine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84313-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84313-001-301 in 1 CARTON06/12/2024
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:84313-001-055 mL in 1 TUBE; Type 0: Not a Combination Product06/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01506/12/2024
Labeler - TINA DAVIES PROFESSIONAL LLC (119265327)
Establishment
NameAddressID/FEIBusiness Operations
THE SKINCARE FOUNDRY LTD230986608manufacture(84313-001)

Revised: 5/2024
Document Id: 9508a7cf-79d1-461f-bcac-10691df87fcf
Set id: 6a2b3199-f405-4455-9a02-8885d24eef9c
Version: 1
Effective Time: 20240530
 
TINA DAVIES PROFESSIONAL LLC