Label: QUICK NUMB- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63742-110-01 - Packager: Clinical Resolution Laboratory, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredient
- Uses:
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Warnings
- If condition worsens or does not improve within 7 days, consult a doctor.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, consult a doctor promptly.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
- Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
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Directions
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
- Apply externally to the affected area up to 6 times daily.
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Other Information
- Keep away from direct sunlight or heat.
- Store at room temperature 15°-30°C (59°-86°F).
- This package is child-resistant. Keep out of reach of children.
- In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
- Do not use this product if seal is broken or missing.
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
QUICK NUMB
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63742-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CHOLESTEROL (UNII: 97C5T2UQ7J) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIDECETH-6 (UNII: 3T5PCR2H0C) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63742-110-01 35.43 g in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/01/2021 Labeler - Clinical Resolution Laboratory, Inc. (825047942) Establishment Name Address ID/FEI Business Operations Clinical Resolution Laboratory, Inc. 825047942 manufacture(63742-110)
