Active Ingredient(S)
Lidocaine HCI 5%
Zeropain 5
FDA Label NDC 83371-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blackbull Store Llc for the product Zeropain 5 (NDC 83371-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - keep out of reach of children, otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Use
Anesthetic anorectal Cream For the temporary relief of pain and itching due to anorectal disorders
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away +1 800-222-1222
Otc - Stop Use
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.
Otc - Questions
Call: (505) 800 6309 www.Zero-Pain.com
Package Label - Principal Display Panel
Ndctopical (Toipicalpic)
2 OZ Cream, NDC: 83371-111-11
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