FDA Label for White Flower Strain Relief

The following document was submitted to the FDA by the labeler of this product Jelma Philippines Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Active ingredients
Camphor 10%
Menthol 15%
Methyl Salicylate 50%

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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