Blackbull Numbed As Fxxk Cream 57 Ml

Blackbull Numbed As Fxxk Cream 57 Ml
SPL v1
SPL
SPL Set ID 0011c61b-e3cd-d909-e063-6394a90a6ac2
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Steareth-21 Isohexadecane Alcohol 95% Phenoxyethanol Cyclomethicone 5 Cetostearyl Alcohol Glyceryl Monostearate .alpha.-tocopherol Acetate, Dl- Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dimethicone Water Ethylhexylglycerin Denatonium Benzoate Anhydrous Jojoba Oil Edetate Disodium Anhydrous Aloe Vera Leaf Dihexadecyl Phosphate Ceteth-10 Phosphate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-10

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Use

For the temporary relief of pain

Section 50565-1

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

Section 50566-9

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.

Section 53413-1

Call (754) 248 - 2548

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.

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

Active Ingredient(s)

Lidocaine 4%

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.

Package Label Principal Display Panel

2 OZ Cream, NDC: 83371-112-11


Structured Label Content

Use

For the temporary relief of pain

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 53413-1 (53413-1)

Call (754) 248 - 2548

Purpose

Topical Anesthetic

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.

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 (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

Active Ingredient(s)

Lidocaine 4%

Inactive Ingredients (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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

2 OZ Cream, NDC: 83371-112-11


Advanced Ingredient Data


Raw Label Data

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