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Package Insert and Label Information: Equaline Muscle Rub Ultra Strength

By Supervalu Inc | Last revised: 4 December 2008

EQUALINE MUSCLE RUB ULTRA STRENGTH- camphor (synthetic), menthol and methyl salicylate cream
Supervalu 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.

Active ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

other than as directed

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad

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
  • redness is present or excessive skin irritation develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • use only as directed
  • adults & 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°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer type C, edetate disodium, glyceryl monostearate, lanolin anhydrous, PEG-100 stearate, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions or comments? 1-877-932-7948

Principal Display Panel

compare to Ultra Strength Bengay® active ingredients

deep penetrating pain relief

fast relief from minor arthritis, backache, muscle & joint pain

contains three pain relieving ingredients

ultra strength

muscle rub

pain relieving cream

non-greasy

Muscle Rub Carton Image 1
(click image for full-size original)

Muscle Rub Carton Image 1

Muscle Rub Carton Image 2
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Muscle Rub Carton Image 2

EQUALINE MUSCLE RUB ULTRA STRENGTH
camphor, menthol, methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-049
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 4 g in 100 g
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
POLYSORBATE 80
POTASSIUM HYDROXIDE
WATER
STEARIC ACID
TROLAMINE
CARBOMER HOMOPOLYMER TYPE C
PEG-100 STEARATE
LANOLIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41163-049-16 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 57 g in 1 TUBE This package is contained within the CARTON (41163-049-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/04/2008
Labeler — Supervalu Inc (006961411)

Revised: 12/2008 Supervalu Inc

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