BLISS REPUBLIC LIDOCAINE NUMBING CREAM- lidocaine numbing cream cream 
Sargass Group Limited Liability Company

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BLISS REPUBLIC LIDOCAINE NUMBING CREAM

Active Ingredient(s)

LIDOCAINE 5%_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Local Anesthetic

Purpose

Topical Anesthetic

Use

For temporary relief of local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorder or inflammation.

Warnings

(For external use only)

Before usage:

Avoid using this product if you have a known allergy to lidocaine.
Do not use while pregnant or breastfeeding.

In case of accidental overdose, seek immediate medical assistance or contact the Poison Control Center.

When using this product:

Adhere to the recommended daily dosage unless otherwise directed by a doctor.
Some individuals with heightened sensitivity might experience allergic reactions to specific ingredients in this product.

Do not insert this cream into the rectum using fingers, applicators, or any medical devices.

Keep away from children. Avoid contact with eyes. In case of accidental ingestion, seek medical attention immefiately.

Discontinue use and consult a doctor if:

The treated symptoms show no signs of improvement, or if redness, irritation, swelling, pain, or other symptoms manifest or worsen. Seek immediate medical attention in such cases.

Directions

Adults: Before applying this product, gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth.

Apply up to 6 times daily. Children under 12 years: consult a doctor.

Other information

Additional Information:

Store at room temperature. Avoid direct sunlight. Refrain from using if packaging has been damaged or is missing.

Inactive ingredients

Carbomer 934, Arnica, Emu oil, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Menthol, Water Floral scent

Package Label - Principal Display Panel

Cream-label30mL NDC: 84028-111-11

BLISS REPUBLIC LIDOCAINE NUMBING CREAM 
lidocaine numbing cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84028-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MENTHOL (UNII: L7T10EIP3A)  
CARBOMER 934 (UNII: Z135WT9208)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84028-111-1130 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
2NDC:84028-111-1255 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
3NDC:84028-111-13100 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/03/2024
Labeler - Sargass Group Limited Liability Company (119155798)

Revised: 2/2024
Document Id: 118044d3-6bba-60c7-e063-6294a90ae2f1
Set id: 0f3daded-c074-4b12-e063-6294a90a0484
Version: 3
Effective Time: 20240216
 
Sargass Group Limited Liability Company