NUMB SOOTHE- lidocaine 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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Numb Soothe

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

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

Warning

For external use only

Do not use this product if:

  • Pregnant or breast-feeding, ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately
  • Tamper Evident "Warranty Void.. Seal.. label atop the container is broken.

When using this product:

  • Do not exceed the recommended 6 times a day.
  • In rare cases allergic reations to ingredients in this product may occur.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Keep out of eyes.

Stop use and ask a doctor if:

the symptom being treated does not subside or if redness, irritation, swrlling, pain or other symptoms develop or increases.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention immediately.

Other Information

  • Keep away from direct sunlight or heat
  • Store in room temperature (59-86 oF/15-30 oC)

Directions:

  • Adults: When practical, deanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry before application of this product.
  • Apply to small area for 15 to 25 minutes
  • Children under 12 years of age: consult a doctor

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Triethanolamine, Carbomer, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polyacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol Allantoin, Tocopheryl Acetate, Bisabolo

Package Labeling

63742-004-00

Package Labeling

63742-004-01

NUMB SOOTHE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TRIDECETH-10 (UNII: G624N6MSBA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63742-004-008 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/201801/01/2018
2NDC:63742-004-0115 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/201801/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/201801/01/2018
Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 12/2018
Document Id: 7e51c738-5d2d-8670-e053-2a91aa0a5af6
Set id: 5d5c41fc-d704-411b-a804-446ebb283afe
Version: 3
Effective Time: 20181231
 
Clinical Resolution Laboratory, Inc.