Otc - Active Ingredient
Active Ingredients Menthol 2.0% Purpose: Topical Analgesic
Mmm Ice Gel
FDA Label NDC 69822-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Services, Inc for the product Mmm Ice Gel (NDC 69822-013). 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, 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
Otc - Purpose
Topical Analgesic
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. Avoid contact with eyes.
Otc - When Using
• do not bandage tightly
• do not apply to wounds or damaged skin
Otc - Stop Use
Stop use and ask a doctor if
• condition worsens • 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
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 a doctor.
Storage And Handling
Other information
• do not freeze
• Keep lid tightly closed
Inactive Ingredient
Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanol- amine, FD&C Blue no. 1, purified water.
Package Label.Principal Display Panel
227 g NDC: 69822-013-80
MMM Therapeutic Ice Gel
Topical Analgesic
Net Wt. 8 oz
* Please review the disclaimer below.
