drug facts

drug facts
SPL v1
SPL
SPL Set ID 70392efa-5b3e-4b5b-81bb-3d1b4e7db955
Route
topical
Published
Effective Date 2014-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (.5 g)
Inactive Ingredients
water isoceteth-20 propylene glycol aloe vera leaf glycerin menthol carbomer copolymer type a (allyl pentaerythritol crosslinked) dmdm hydantoin phenoxyethanol methylparaben propylparaben trolamine arnica montana flower comfrey leaf tea tree oil fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-01-01
Purpose

Temporarily Relieves pain due to: sunburn minor burns

Description

Lidocaine 0.5%

Medication Information

Warnings

For external use only.  Do not swallow.  Avoid contact with eyes.  If contacted, flush eyes with water.  Should a rash or irritation develops, discontinue use.  If condition worsens, or if symptoms persist for more than 7 days, consult a physician.  Do not use in large quantities, particularly over raw surfaces or blistered areas.  Keep out of the reach of children.

Uses

Temporarily Relieves pain and itching due to:

  • sunburn
  • minor burns
Purpose

Temporarily Relieves pain due to:

  • sunburn
  • minor burns
Directions

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily.  Children under 2 years of age, consult a physician.

Description

Lidocaine 0.5%

Section 44425-7


  • protect this product from excessive heat and direct sun
  • for use on skin only


Section 51945-4

Active Ingredient

Lidocaine 0.5%

Inactive Ingredient Section

Inactive Ingredients: Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, CI 42090, DMDM Hydantoin, Fragrance, Glycerin, Isoceteth-20, Melaleuca Alternifolia (Tea Tree Oil), Menthol, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Symphytum Officinale (Comfrey) Extract, Triethanolamine, Water

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.

Structured Label Content

Warnings

For external use only.  Do not swallow.  Avoid contact with eyes.  If contacted, flush eyes with water.  Should a rash or irritation develops, discontinue use.  If condition worsens, or if symptoms persist for more than 7 days, consult a physician.  Do not use in large quantities, particularly over raw surfaces or blistered areas.  Keep out of the reach of children.

Uses

Temporarily Relieves pain and itching due to:

  • sunburn
  • minor burns
Purpose

Temporarily Relieves pain due to:

  • sunburn
  • minor burns
Directions

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily.  Children under 2 years of age, consult a physician.

Section 44425-7 (44425-7)


  • protect this product from excessive heat and direct sun
  • for use on skin only


Section 51945-4 (51945-4)

Active Ingredient

Lidocaine 0.5%

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, CI 42090, DMDM Hydantoin, Fragrance, Glycerin, Isoceteth-20, Melaleuca Alternifolia (Tea Tree Oil), Menthol, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Symphytum Officinale (Comfrey) Extract, Triethanolamine, Water

Keep Out of Reach of Children (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:46.354730 · Updated: 2026-03-14T22:53:43.600487