OTC Medication Information: Muscle Rub Ultra

MUSCLE RUB ULTRA- menthol, camphor (natural) and menthyl salicylate, (+/-)- cream
H E B

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.

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Uses

temporarily relieves the minor aches and pains of muscle and joints associated with:

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains

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

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

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Use only as directed
  • 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

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

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MUSCLE RUB ULTRA
camphor,menthol, methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-773
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 4 g in 100 g
MENTHYL SALICYLATE, (+/-)- (SALICYLIC ACID) MENTHYL SALICYLATE, (+/-)- 30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
LANOLIN
POLYSORBATE 80
POTASSIUM HYDROXIDE
STEARIC ACID
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-773-04 1 TUBE in 1 BOX contains a TUBE
1 113 g in 1 TUBE This package is contained within the BOX (37808-773-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/25/2011
Labeler — H E B (007924756)

Revised: 05/2018 H E B

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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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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