Bengay Ultra Strength Patch
FDA Label NDC 69968-0487

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Bengay Ultra Strength (NDC 69968-0487). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: JOHNSON & JOHNSON COMSUMER INC.
Skillman, NJ 08558

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

calcined kaolin, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, polyacrylic acid, polysorbate 80, propylparaben, silica, sodium polyacrylate, sodium polyacrylate starch, sorbitan oleate, sorbitol, tartaric acid, titanium dioxide, water

Questions?

call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

Principal Display Panel - 1 Patch Pouch Carton

BENGAY®
MENTHOL 5% TOPICAL
ANALGESIC PATCH

ULTRA STRENGTH
PAIN RELIEVING
PATCH
Targeted relief that's
designed to stay in place

4
LARGE
FOR BACK TO HIP

4 INDIVIDUALLY SEALED PATCHES
3.9 IN x 7.9 IN (10 cm x 20 cm)

Principal Display Panel (1 Patch Pouch Carton)

Principal Display Panel (1 Patch Pouch Carton)

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