OTC Medication Information: Ultra Strength Pain Relief Balm

ULTRA STRENGTH PAIN RELIEF BALM- camphor (natural) and menthol gel
McCure Health Solutions Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Camphor 11%

Menthol 11%

Purpose

Topical analgesic

Uses

For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Warnings

For external use only

When using this product

  • Avoid contact with eyes and mocous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Stop use and ask a doctor if

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

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 immediately.

Directions

  • Rub well on the affected area. Repeat 3 to 4 times daily

Other information

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

Inactive ingredients

CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA

Product Label

PAIN RELIEF BALM
(click image for full-size original)

ULTRA STRENGTH PAIN RELIEF BALM
camphor, menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52486-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 110 mg in 1 g
MENTHOL (MENTHOL) MENTHOL 110 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAJUPUT OIL
CLOVE OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52486-013-18 1 TUBE in 1 CARTON contains a TUBE
1 18 g in 1 TUBE This package is contained within the CARTON (52486-013-18)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/27/2015
Labeler — McCure Health Solutions Inc. (053034873)
Establishment
Name Address ID/FEI Operations
Jiangsu Dedi Medical Device Co., Ltd. 544458936 manufacture (52486-013)

Revised: 12/2016 McCure Health Solutions Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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