SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL- lidocaine, phenylephrine hydrochloride gel 
LALANI Rx Consulting, Inc.

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SECONDARY NUMB Lidocaine/Phenylephrine Gel

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:

Label

SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL 
lidocaine, phenylephrine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83120-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83120-378-001 in 1 BOX10/10/2022
131.18 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01510/10/2022
Labeler - LALANI Rx Consulting, Inc. (243276725)

Revised: 11/2023
Document Id: 0976eff9-48c6-1669-e063-6394a90a8240
Set id: 0f13f7b5-e3b1-451e-a6d6-e7e15bd04443
Version: 2
Effective Time: 20231106
 
LALANI Rx Consulting, Inc.