Ultra Strength Pain Relief Balm
FDA Label NDC 76168-331

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Ultra Strength Pain Relief Balm (NDC 76168-331). 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, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Camphor 11%Topical Analgesic
Menthol 11%Topical Analgesic

Uses

See outer packaging for full uses.

Warnings

For External Use Only

When Using This Product

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with wrap or use heating pad
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

Stop Use And Ask A Doctor If

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
  • Pain clears up and then recurs a few days later.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare 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 immediately.

Directions

  • For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily
  • For children 12 years of age or younger, consult a doctor before use.

Other Information

This product may cause allergic reaction on some individuals. Test on small area before use.

Questions

1-855-314-1850

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