Label: TINA DAVIES ICECREAM- lidocaine hydrochloride, phenylephrine hydrochloride cream
- NDC Code(s): 84313-001-05, 84313-001-30
- Packager: TINA DAVIES PROFESSIONAL LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 30, 2024
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- Drug Facts
- Active ingredients
- Purpose
- Uses
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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. -
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
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
TINA DAVIES ICECREAM
lidocaine hydrochloride, phenylephrine hydrochloride creamProduct 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)