Otc - Active Ingredient
Active ingredients
Camphor 10%
Menthol 15%
Methyl Salicylate 50%
White Flower Strain Relief
FDA Label NDC 51681-0041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jelma Philippines Inc for the product White Flower Strain Relief (NDC 51681-0041). 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 - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Purpose
External Analgesic
Indications & Usage
Uses
Tempoarily relieves minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
■ on wounds
■ on irritated or damaged skin
■ otherwise than as directed
Otc - When Using
When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ when using for pain of arthritis:
■ pain persists for more than 10 days
■ redness is present
■ in conditions affecting children under 12 years of age
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily.
After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
■ children under 3 years of age: do not use, consult your physician
■ refer to the above warnings; use otherwise than as directed may be dangerous
Storage And Handling
Other information
■ store at 15° to 30° C (59° to 86° F)
■ keep container tightly closed
Inactive Ingredient
Inactive ingredients
Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.
Otc - Questions
Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
Package Label.Principal Display Panel
WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL NDC 48256-0041-1 1.7 FL OZ (50 ML)
Image Of Carton 50ml (Box1)
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