Active Incredient
Menthol, 4%
Lumina Natures Creation Unveiled
FDA Label NDC 58133-591
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 Lumina Natures Creation Unveiled (NDC 58133-591). 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 incredient, purpose, uses, warnings, otc - when using, otc - stop use, 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
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 prodcut•use only as directed •avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin •do not bandage tightly
Otc - Stop Use
Stop use and ask a physician if•condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days •redness is present •irritation develops
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children . If case of accidental ingestion, get medical help or contact a poison Control Center right away.
Directions:
Adults and children 2 years of age and older:•apply generously to affected area •massage into painful area until thoroughly absorbed into skin •repeat as necessary, but no more than 4 time daily
Children under 2 years of age: ask a doctor
Recent Major Changes
effective date update and wording of Directions for Use updated to match label
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Juice, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cyanocobalamin, Mentha piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Polysorbate-60, Purified Water, Salix alba (Willow) Bark Extract, Sodium Hyaluronate, Sorbitol, Triethanolamine
Package Label
3 Oz Roll-on (Oasis Lumina Label 021023)
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