Otc - Active Ingredient
Active ingredient
Menthol 5%
External Analgesic Cream With Menthol 5% Cream
FDA Label NDC 85284-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product External Analgesic Cream With Menthol 5% (NDC 85284-010). 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, inactive ingredient, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,
Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,
Mentha Arvensis Leaf, Chrysanthemum Indicum Top,
Portulaca, Polyoxyl 40 Hydrogenated Castor Oil
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains
Warnings
For external use only
Otc - When Using
avoid contact with eyes,
mucous membranes do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if: condition worsens
symptoms persist for more than 7 days
symptoms 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Dosage & Administration
- Adults and children 12 years and older:
Clean the affected area with mild soap and warm water, then pat dry.
Apply a thin, even layer to the affected area not more than 3 to 4 times
daily.
- Children under 12 years: consult a doctor
Otc - Purpose
Temporary relief of minor aches and pains
Otc - Do Not Use
on wounds or damaged skin with a heating pad
if allergic to menthol or any ingredient in this product
Other Safety Information
Store at 15–30°C (59–86°F)
Protect from excessive moisture and direct sunlight
Keep the carton for full labeling
Flammable: keep away from fire or flame
* Please review the disclaimer below.
