SPL v3
SPL
SPL Set ID 26ce6127-c90e-4c96-85b9-1a4560c5f144
Route
TOPICAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Butylene Glycol Steareth-21 Steareth-2 Cetyl Alcohol Cannabis Sativa Seed Oil Glycerin Caprylyl Glycol Hemp Tocopherol Arnica Montana Flower Indian Frankincense Plantago Major Leaf Phenoxyethanol Hexylene Glycol Xanthan Gum .alpha.-hexylcinnamaldehyde Coumarin Limonene, (+)- Peppermint

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-03

Description

Lidocaine HCL 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCL 4%

Uses

Temporarily relieves pain and itching

Warnings
  • For external use only Use only as direacted
  • Do not allow contact with the eyes and mucuous membrances.
  • Do not apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics 
  • Stop use and ask a doctor if: allergic reaction occurs 
  • condition worsen or does not improve within 7 days 
  • redness, irritation, swelling, pain or other symptoms begin or increase.
  • If pregnant or Breastfeeding 

   Ask a health professional before use.

Keep out of reach of children 

  If swallowed, get medical help or Contact a Posion Control right away. Emergency number : 1-800-222-1222

Direaction

    Adults and children 12 years of age or older:

  • Apply to affected area not more than 3 to 4 times daily
  • Children under two years of age, consult a physicion
Product Label

Active Ingredient

Lidocaine HCL 4%

Inactive Ingredients

Aqua, Alcohol Denat., Butylene Glycol, Steareth-21, Steareth-2, Cetyl Alcohol, Hemp Seed Oil, Glycerin, Caprylyl Glycol, Kannopia-Active TM Proprietary Hemp Extract, Tocopherol, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Extract, Plantago Major (Plantain) Leaf

Extract, Phenoxyethanol, Hexelene Glycol, Xanthan Gum, Hexyl Cinnamic Aldehyde, Coumarin, Limonene, Peppermint

Additional Information

Store in a cool, dry place


Structured Label Content

Uses

Temporarily relieves pain and itching

Purpose

Topical Analgesic

Warnings
  • For external use only Use only as direacted
  • Do not allow contact with the eyes and mucuous membrances.
  • Do not apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics 
  • Stop use and ask a doctor if: allergic reaction occurs 
  • condition worsen or does not improve within 7 days 
  • redness, irritation, swelling, pain or other symptoms begin or increase.
  • If pregnant or Breastfeeding 

   Ask a health professional before use.

Keep out of reach of children 

  If swallowed, get medical help or Contact a Posion Control right away. Emergency number : 1-800-222-1222

Direaction

    Adults and children 12 years of age or older:

  • Apply to affected area not more than 3 to 4 times daily
  • Children under two years of age, consult a physicion
Product Label (Product label)

Active Ingredient

Lidocaine HCL 4%

Inactive Ingredients (Inactive ingredients)

Aqua, Alcohol Denat., Butylene Glycol, Steareth-21, Steareth-2, Cetyl Alcohol, Hemp Seed Oil, Glycerin, Caprylyl Glycol, Kannopia-Active TM Proprietary Hemp Extract, Tocopherol, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Extract, Plantago Major (Plantain) Leaf

Extract, Phenoxyethanol, Hexelene Glycol, Xanthan Gum, Hexyl Cinnamic Aldehyde, Coumarin, Limonene, Peppermint

Additional Information (Additional information)

Store in a cool, dry place


Advanced Ingredient Data


Raw Label Data

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