DOCTOR BUTLERS NUMB IT ALL CREAM- lidocaine 5% cream 
Beyond Health, P.A.

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.

----------

Doctor Butler's Numb-It-All-Cream

Lidocaine 5.0%

Local Anesthetic

Uses

Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

For external use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a professional before use.

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Calendula Officinalis flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.

Label

DOCTOR BUTLERS NUMB IT ALL CREAM 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
TURMERIC (UNII: 856YO1Z64F)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CARYA OVATA BARK (UNII: X765CF609L)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ROSEMARY (UNII: IJ67X351P9)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-183-0142.5 g in 1 JAR; Type 0: Not a Combination Product03/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2022
Labeler - Beyond Health, P.A. (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derrma Care Research Labs116817470manufacture(70942-183)

Revised: 3/2022
Document Id: d929d4f9-2194-0c4b-e053-2995a90a7435
Set id: d929d4f9-2193-0c4b-e053-2995a90a7435
Version: 1
Effective Time: 20220301
 
Beyond Health, P.A.