Painbloc24 Prowomen Pain Relief Patch
FDA Label NDC 71226-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vizuri Health Sciences Llc for the product Painbloc24 Prowomen Pain Relief Patch (NDC 71226-003). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Menthol 6%

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated
with:
▪ simple backache
▪ muscle strains
▪ arthritis
▪ bruises
▪ sprains

Warnings

For external use only
When using this product
▪ use only as directed
▪ do not bandage tightly
▪ do not use with heating pad
▪ avoid contact with eyes and mucous membranes
▪ do not apply to wounds, damaged, broken or irritated skin
▪ do not use at the same time as other topical analgesics
Stop use and ask a doctor if
▪ condition worsens
▪ redness or irritation develops
▪ symptoms last more than 7 days or clear up and occur again within a few days
▪ you experience burning, swelling or blistering where applied
If pregnant or breast-feeding ask a healthcare professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years:
▪ clean and dry affected area
▪ trim excessive hair for better adhesion
▪ open pouch and remove patch
▪ remove backing from patch by grasping both ends and pulling backing apart
▪ peel off one half of backing and place patch onto affected area
▪ peel off other half of backing and press and smooth onto skin

  • use patch as needed for up to 8 hours. Do not remove when wet or directly after showering or bathing. Allow patch to dry and then slowly remove.
  • use on affected area no more than 3-4 times daily.

    • Children under 12 years : consult doctor

Other Information

Store in cool dry place at room temperature

Inactive Ingredients

Acrylic Adhesive, Chaste Tree Berry (Vitex), d-limonene, Dipropylene glycol, Lavender,
Lemon Balm, Magnesium Chloride, Polysorbate 80, Tocopheryl Acetate, White Curcumin

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