Otc - Active Ingredient
Benzalkonium Chloride 0.1%
Gelle-n-detox Ice Mint And Eucalyptus Massage Lotion
FDA Label NDC 49283-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chemco Corporation for the product Gelle-n-detox Ice Mint And Eucalyptus Massage (NDC 49283-014). 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, uses, warnings, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Uses
First aid to help protect against bacterial contamination.
Warnings
- For external use only.
- Do not use in the eyes or apply over large areas of the body.
- In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
- Stop use and ask a doctor if the condition persists or gets worse.
- Do not use longer than 1 week unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have redness over affected area.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center
right away
Directions
Adults and children 12 years of age or older: • Clean the affected area. • Apply a small amount of this product on the area 1 to 3 times daily. • May be covered with a sterile bandage. Children under 12 years of age: do not use, consult a doctor.
Other Safety Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Water (Aqua), Paraffinum Liquidum, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Fragrance (Parfum), DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Methyl Salicylate, Eucalyptus Globulus Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Citral, D-Limonene, Geraniol, Linalool.
Otc - Questions
Call (305) 623-4445
* Please review the disclaimer below.
