Label: LIDOCAINE- lidocaine spray spray
- NDC Code(s): 83365-002-01
- Packager: Sichuan Gumo Brand Management Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
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 April 18, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor. -
Do not use
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor. -
When using
When using this product
do not exceed the recommended the daily usage.
certain persons can develop allergic reactions to ingredients in this product.
do nut put this product into the rectum by using finger or any medical device or applicator.
If swallowed, call your Poison Control Center immediately. If condition worsens or does not improve within 7 days, consult a doctor - Stop use
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Directions
Cleanse the affected area.
Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect.
apply to the affected area up to 4 times daily.
children under 12 years of age: consult a doctor. - Other Information
- Inactive Ingredients
- Keep Out Of
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine spray sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83365-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) WATER (UNII: 059QF0KO0R) SODIUM SULFITE (UNII: VTK01UQK3G) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ARGININE (UNII: 94ZLA3W45F) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83365-002-01 141 g in 1 BOX; Type 0: Not a Combination Product 03/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/25/2023 Labeler - Sichuan Gumo Brand Management Co.,Ltd (406945503) Establishment Name Address ID/FEI Business Operations Sichuan Gumo Brand Management Co.,Ltd 406945503 manufacture(83365-002)
