Label: ARTHRI-ZEN RELIEF- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 34876-001-24 - Packager: RZN Nutraceuticals, Inc.
- 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 December 20, 2013
If you are a consumer or patient please visit this version.
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• Adults and children under 12 years of age and older: apply to affected area
no more than 3 to 4 times daily.
• Children under 12: consult a physician.
• Apply generously and massage into affected areas
until completely absorbed.
• Apply before and after sports or exercise to help soothe aching muscles, muscle strain, and stiffness.
Repeat as needed up to four times a day.
- Other Information
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Inactive Ingredients
Water, Methyl Glucose Sesquistearate, Arthri-Zen Relief Proprietary Herbal Extract
Blend, Natural Oil of Wintergreen (Gaultheria procumbens), Avocado Oil (Persea gratissima), Stearic Acid, Aloe
(Aloe barbadensis), Grape Seed Oil (Vitis vinifera), Cyclomethicone, Shea Butter (Butyrospermum parkii),
Steareth-10, Phenoxyethanol, Ceteareth-20, Steareth-2.
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DESCRIPTION
This product is manufactured exclusively for: RZN Nutraceuticals, Inc. Miami, FL 33186
• Soothing and medicated analgesic
rub for aching joints and muscles
• Effective for pre-exercise warm-up
• Deep penetrating therapeutic pain relief
• With skin moisturizing conditioners
aloe, shea butter, avocado, and
grape seed oil
• Contains Arthri-Zen Relief’s
clinically tested herbal formula
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INGREDIENTS AND APPEARANCE
ARTHRI-ZEN RELIEF
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34876-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) AVOCADO OIL (UNII: 6VNO72PFC1) STEARIC ACID (UNII: 4ELV7Z65AP) ALOE VERA LEAF (UNII: ZY81Z83H0X) GRAPE SEED OIL (UNII: 930MLC8XGG) CYCLOMETHICONE (UNII: NMQ347994Z) SHEA BUTTER (UNII: K49155WL9Y) STEARETH-10 (UNII: FD0913P475) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) STEARETH-2 (UNII: V56DFE46J5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34876-001-24 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/01/2007 Labeler - RZN Nutraceuticals, Inc. (019943765) Establishment Name Address ID/FEI Business Operations Accupack Midwest 139637433 manufacture(34876-001)