Dg Health Extra Strength Medicated
FDA Label NDC 55910-391

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp Inc for the product Dg Health Extra Strength Medicated (NDC 55910-391). 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, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                             Purpose

Menthol 5%...................................................................Topical analgesic


Otc - Purpose

Uses Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin, broken or irritated skin

Otc - Stop Use

Stop use and ask a doctor if

  • conditions worsens
  • redness is present
  • irritation develops
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin, broken or irritated skin

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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.

Indications & Usage

Directions adults and children over 12 years

  • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • apply one patch to affected area
  • repeat as necessary, but no more than 3 times daily
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient

Inactive ingredients aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminate metasilicate, methyl paraben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Dosage & Administration

DISTRIBUTED BY

DOLGEN CORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN KOREA

Package Label.Principal Display Panel

Image Of Carton Label (Dghealthmedicated)

Image Of Carton Label (Dghealthmedicated)

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