SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL- lidocaine, phenylephrine hydrochloride gel

SECONDARY NUMB Lidocaine Phenylephrine Gel by

Drug Labeling and Warnings

SECONDARY NUMB Lidocaine Phenylephrine Gel by is a Otc medication manufactured, distributed, or labeled by LALANI Rx Consulting, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (w/w)

Lidocaine 5% Phenylephrine HCL 0.25%

Purpose

Local Anesthetic

Vaso Constrictor

Uses

Temporary relief of pain Temporarily shrinks hemorrhoidal tissue For the temporary relief of anorectal discomfort associated with hemorrhoids

Warnings

For external use only

Do not use

if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination

Ask a doctor before use if you are

presently taking medicine for high blood pressure or depression

When using this product

do not put it into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

bleeding occurs condition worsens or does not improve within 7 days  redness, irritation, swelling, pain or other symptoms occur. If allergic  reaction to product occurs.

Keep out of reach of children.

If swallowed, call poison control centre or get medical help right away

Directions

Adults and children 12 years and over: Children under 12 consult a doctor Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product Apply to the affected area up to 3 times daily Do not use more often than directed

Inactive ingredients

Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol

Questions?

1-844-782-2387

Package Labeling:

INGREDIENTS AND APPEARANCE

SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL 
lidocaine, phenylephrine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83120-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83120-378-00	1 in 1 BOX	10/10/2022
1		31.18 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
OTC Monograph Drug	M015	10/10/2022

Labeler - LALANI Rx Consulting, Inc. (243276725)