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Drug Facts
Select Brand Anti-itch
FDA Label NDC 15127-721
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Brand for the product Select Brand Anti-itch (NDC 15127-721). 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 other, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, 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
Active Ingredients
Menthol 1%
Pramoxine hydrochloride 1%
Purpose
Topical analgesic
Uses
for temporary relief of pain and itching due to:
- minor burns
- sunburn
- minor cuts
- scrapes
- insect bites
- minor skin irritations
- minor rashes due to poison ivy, poison oak, or poison sumac
Warnings
For external use only
When Using This Product
do not get into eyes
Stop Use And Ask A Doctor If
- condition gets worse
- symptoms last 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.
Directions
adults and children 2 years and older: apply to affected area not more than 3 or 4 times daily
children under 2 years: consult a doctor
Other Information
- store at controlled room temperature
Inactive Ingredients
aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum
Principal Display Panel
Select Brand Medicated Anti-Itch Cream
Maximum Relief
Topical Analgesic
Net wt 1 oz (28.3 g)
Pdp (Sb Med Crm Box Front)
Rear (Sb Med Crm Back Box)
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