Dynarub (Pain Relieving Cream) Cream [Dynarex Corporation] -

DYNARUB (PAIN RELIEVING CREAM) CREAM [DYNAREX CORPORATION]
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Active Ingredient

Menthol 10%
Purpose

Topical Analgesic
Active Ingredient

Methyl Salicylate 15%
Purpose

Topical Analgesic
Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains
Warnings
For external use only

Do not use on

wounds or damaged skin
When using this product
- avoid contact with eyes
- do not bandage tightly
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: Consult a doctor
Other Information

store at 20°-25°C (68°-77°F).
Inactive Ingredients

Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum
Label

INGREDIENTS AND APPEARANCE

DYNARUB
pain relieving cream cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-113-50	72 in 1 CASE	09/12/2016
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/12/2016

Labeler - Dynarex Corporation (008124539)

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