Ultra Strength Pain Relief Balm

Ultra Strength Pain Relief Balm
SPL v3
SPL
SPL Set ID 5f791159-c388-4c77-8aca-35e4c3f7cacd
Route
TOPICAL
Published
Effective Date 2020-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (110 mg) Menthol, Unspecified Form
Inactive Ingredients
Cajuput Oil Padang Cassia Oil Clove Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-10
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

See outer packaging for full uses.

Section 42229-5

Drug Facts

Section 50565-1

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

Section 51945-4

Section 53414-9

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

Section 55105-1
Active Ingredients Purpose
Camphor 11% Topical Analgesic
Menthol 11% Topical Analgesic
Warnings

For External Use Only

Questions

1-855-314-1850

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.

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

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.

Structured Label Content

Uses

See outer packaging for full uses.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredients Purpose
Camphor 11% Topical Analgesic
Menthol 11% Topical Analgesic
Warnings

For External Use Only

Questions

1-855-314-1850

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 (Other information)

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

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

When Using This Product (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 (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:23.599643 · Updated: 2026-03-14T23:00:47.249871