Active Ingredient
Menthol, 3.0%
Control Menstrual Cramp Relief
FDA Label NDC 58133-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Control Menstrual Cramp Relief (NDC 58133-010). 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 active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
Warnings
for external use only
Otc - When Using
When using this product use only as directed • avoid contact with eyes or mucous membranes • 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 • redness is present • irritation develeps
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions
Adults and children over 12 years:• apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily
Children 12 years or younger: ask a doctor
Inactive Ingredients
Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, Stearic Acid, Triethanolamine.
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