releaf technologies (as pld) - releafpeak (78663-211)

releaf technologies (as pld) - releafpeak (78663-211)
SPL v1
SPL
SPL Set ID 09c0b3ec-2857-7dbd-e063-6294a90a8052
Route
topical
Published
Effective Date 2003-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g) menthol (1 g)
Inactive Ingredients
trolamine trideceth-6 alpha-tocopherol acetate medium-chain triglycerides water hemp shea butter cetostearyl alcohol polysorbate 60 glyceryl monostearate dimethicone phenoxyethanol ethylhexylglycerin aloe vera leaf arnica montana acrylic acid/sodium acrylate copolymer (1:1; 600 mpa.s at 0.2%) mineral oil cyclomethicone 5

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-09
Purpose

TOPICAL ANALGESIC

Description

Lidocaine 4% Menthol 1%

Medication Information

Uses

For temporary relief of pain and itching due to anorectal disorders

Purpose

TOPICAL ANALGESIC

Directions

Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor.

Other Information

Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

Inactive Ingredients

Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,

Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.

Description

Lidocaine 4% Menthol 1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Warning

For external use only.



Do not use large quantities, particularly over raw surfaces or blistered areas.



When using this product avoid contact with the eyes.



Stop using and ask a doctor if

  • the condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • a rash or irritation develops.
Active Ingredient

Lidocaine 4%

Menthol 1%

Structured Label Content

Uses (USES)

For temporary relief of pain and itching due to anorectal disorders

Purpose (PURPOSE)

TOPICAL ANALGESIC

Directions (DIRECTIONS)

Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor.

Other Information (OTHER INFORMATION)

Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

Inactive Ingredients (INACTIVE INGREDIENTS)

Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,

Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Warning (WARNING)

For external use only.



Do not use large quantities, particularly over raw surfaces or blistered areas.



When using this product avoid contact with the eyes.



Stop using and ask a doctor if

  • the condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • a rash or irritation develops.
Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 4%

Menthol 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.198946 · Updated: 2026-03-14T23:01:45.300207