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Drug Facts
Ice Quake Gel
FDA Label NDC 69822-100
11 label sections · Submitted to the FDA by Southern Sales & Service, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Ice Quake (NDC 69822-100). 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, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 15%
Purpose
Topical Analgesic
Uses
For temporary relief of minor pain associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
Avoid contact with eyes. For external use only.
When Using This Product
- do not bandage tightly
- do not apply to wounds or damaged skin.
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
apply to affected area not more than 3 to 4 tmes daily. Adults and children 18 years of age and older:
consult a doctor. Children under 18 years of age:
Inactive Ingredients
glycerine, FD&C blue no. 1, carbopol, hydroxypropyl methylcellulose, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, purified water.
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