Numb520

Numb520

Drug Labeling and Warnings

Drug Details

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NUMB520- lidocaine hydrochloride cream 
Clinical Resolution Laboratory, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Numb520

DRUG FACTS

Active Ingredient

Lidocaine HCl 5%

Purpose

Local Anesthetic

Uses:

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Warnings

(For external use only)

Do not use this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • tamper evident "Do not use this product" if seal is broken or missing.

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using finger or any medical device or applicator.

Stop use and ask a doctor if

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase

Keep out of reach of children

In case of accidental ingestion, seek medical attention immediately.

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 up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

  • keep away from direct sunlight or heat.
  • store in room temperature (59-86°F/15-30°C)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

Package Labeling:

Label

NUMB520 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63742-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63742-030-00125 g in 1 BOTTLE; Type 0: Not a Combination Product09/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/12/2019
Labeler - Clinical Resolution Laboratory, Inc. (825047942)
Establishment
NameAddressID/FEIBusiness Operations
Clinical Resolution Laboratory, Inc.825047942manufacture(63742-030) , label(63742-030) , pack(63742-030)

Revised: 3/2020
 
Clinical Resolution Laboratory, Inc.


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