Anti-itch
FDA Label NDC 55910-407

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Anti-itch (NDC 55910-407). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Otc - Purpose

Purpose

Anti-itch, Pain relief

Indications & Usage

Uses

for temporary relief of pain and itching associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • rashes due to poison ivy, poison oak or poison sumac
  • scrapes
  • insect bites

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

Otc - When Using

When using this product

  • do not get into eyes or nose
  • not for prolonged use

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • if redness, irritation, swelling or pain persists or increases

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

Inactive Ingredient

Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

Other

Other information

  • store at room temperature
  • for lot no. and exp. date, see crimp of tube or see box

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

Label Of Anti-itch (Anti Itch)

Label Of Anti-itch (Anti Itch)

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