Rite Aid Soothing Medicated Anit-itch
FDA Label NDC 11822-0415

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Soothing Medicated Anit-itch (NDC 11822-0415). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                 PurposeMenthol 1%....................................................Pain RelieverPramoxine Hydrochloride 1%............................External Analgesic

Otc - Purpose

UsesFor the temporary relief of pain and discomfort caused by- minor burns - sunburn - scrapes - insect bites- minor skin irritations - rashes due to poison ivy, oak and sumac

Otc - 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.

Indications & Usage

UsesFor the temporary relief of pain and discomfort caused by - minor burns - sunburn - scrapes - insect bites - minor skin irritations - rashes due to poison ivy, oak and sumac

Warnings

Warnings - For external use only- Avoid contact with the eyesDo Not use - under bandages or compresses Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions- Adults and children 2 years and older: apply to affected area not more than 2 times daily- Children under 2 years of age: do not use, consult a doctorOther informationStore at room temperature. Lot No. and Exp. Date: see crimp of tube or see box.

Inactive Ingredient

Inactive Ingredientsaloe barbadensis leaf juice, diazolidinyl urea, disodium EDTA, eucalyptus globules leaf oil, iodopropynyl butylcarbamate, methyl salicylate,petrolatum, PPG-1 trideceth-6, propylene glycol, purified water, sodium acrylates copolymer, steareth-2 steareth-21, stearyl alcohol, thymol, tocopheryl acetate, triethanolamine

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