Otc - Active Ingredient
Active Ingredient Purpose
Menthol 0.31% topical analgesic ointment
Aloemint Skin Aid
FDA Label NDC 10578-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Aloemint Skin Aid (NDC 10578-002). 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, indications & usage, warnings and precautions, otc - ask doctor, otc - keep out of reach of children, dosage & administration, otc - questions, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses: Temporary relief of pain and itching associated with minor cuts and burns, scrapes, and insect bites.
Warnings And Precautions
Warnings: For external use only.
Avoid contact with the eyes.
This product contains components that are flammable. Keep away from fire or open flame. Do not add this product to hot water. Improper use may cause mixture to splatter and cause burns.
Do not:
use on wounds or damaged skin
bandage tightly
Otc - Ask Doctor
Stop using 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.
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.
Dosage & Administration
Directions:
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: consult physician.
Otc - Questions
Other information:
To reorder call: 1-800-644-8327
website: www.botanicchoice.com
Use only of seal is unbroken
Other
Manufactured by: Indiana Botanic Gardens, Inc.
NDC# 1057800202
Inactive Ingredient
Inactive ingredients: yellow petrolatum, natural lanolin (anhydrous), camphor, goldenseal powder, SDA alcohol, aloe vera juice concentrate, thyme oil
Package Label.Principal Display Panel
Picture Of Label (2oz Aloemintskinaid)
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