Otc - Active Ingredient
Lidocaine HCl 4%
Rite Aid Pain Relieving Roll-on Liquid
FDA Label NDC 11822-9989
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 Pain Relieving Roll-on (NDC 11822-9989). 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, uses, warning, otc - do not use, otc - when using, otc - stop use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Anesthetic
Uses
Temporarily relieves minor pain
Warning
For External use only
Otc - Do Not Use
Do not use■on large areas of the body or on cut, irritated or swollen skin ■on puncture wounds ■ for more than one week without consulting a doctor
Otc - When Using
When using this product
■use only as directed. Read and follow all directions and warnings on this carton
■ do not allow contact with the eyes and mucous membranes
■do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■do not use at the same time as other topical analgesics
Otc - Stop Use
Stop use and ask a doctor if
■condition worsens ■ redness is present
■irritation develops
■symptoms persist for more than 7 days or clear up and occur again within a few days
Other Safety Information
Flammable
Keep away from fire or flame
Store at room temperature
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out if reach of children and pets
If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away
Directions
Directions
adults and children over 12 years:■apply a thin layer to affected area every 6 to 8 hours, not to
exceed 3 applications in a 24 hour period.
children 12 years or younger: ■ask a doctor
Inactive Ingredient
Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, amynomethylpropanol, cetelh-10 phosphate, cetostearyl alcohol, cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S at 1.5%), sohexadecane, phenoxyethanol, SD alcohol, steareth-21, water
Otc - Questions
Call 1-866-326-1313
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