NUMBED AS FXXK- topical anesthetic cream cream 
Blackbull Store LLC

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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BlackBull Numbed As FXXK Cream 57 mL

Active Ingredient(s)

Lidocaine 4%

Purpose

Topical Anesthetic

Use

For the temporary relief of pain

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away +1 800-222-1222

Stop Use and Ask a Doctor if the condition worsens ■ symptoms persist for more than seven days or clear up and occur again within a few days. Rash or irritation develops, persists, or increases. If pregnant or breastfeeding, ask a health professional before use.

Directions

Adults and children 2 years old and older Clean the affected area Apply to affected area not more than 3 to 4 times daily Remove residue if desired Children under 2 years old: Consult a doctor

Other information

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclopentasiloxane, Denatonium Benzoate,Dicetyl Phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Gyceryl Stearate, lsohexadecane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Maltodextrin, Phenoxyethanol, Simmondsia Chinensis(Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Water.

Call (754) 248 - 2548

Package Label - Principal Display Panel

Label 57mL2 OZ Cream, NDC: 83371-112-11

NUMBED AS FXXK 
topical anesthetic cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83371-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
STEARETH-21 (UNII: 53J3F32P58)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ALCOHOL 95% (UNII: 7528N5H79B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
JOJOBA OIL (UNII: 724GKU717M)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83371-112-1157 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/2023
Labeler - Blackbull Store LLC (085247371)

Revised: 7/2023
Document Id: 0011c61b-e3ce-d909-e063-6394a90a6ac2
Set id: 0011c61b-e3cd-d909-e063-6394a90a6ac2
Version: 1
Effective Time: 20230709
 
Blackbull Store LLC