Label: DYNARUB- pain relieving cream cream
- NDC Code(s): 67777-113-49, 67777-113-50
- Packager: Dynarex Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated November 16, 2022
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- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
DYNARUB
pain relieving cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-113-50 72 in 1 CASE 09/12/2016 1 NDC:67777-113-49 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/12/2016 Labeler - Dynarex Corporation (008124539)