Label: ROOTREE TREETHERAPY MOBIFERA HAND RELIEF- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72441-020-01, 72441-020-02 - Packager: KTCS Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 30, 2018
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water,Butyrospermum Parkii (Shea) Butter,Glycerin,Cetearyl Alcohol,Hyaluronic Acid,Glyceryl Stearate,PEG-100 Stearate,Helianthus Annuus (Sunflower) Seed Oil,Dendropanax Morbifera Extract,Mentha Arvensis Leaf Extract,Brassica Napus Extract,Citrus Sudachi Fruit Juice,Benzyl Alcohol,Butylene Glycol,Milk Protein Extract,Silkworm Cocoon Extract,1,2-Hexanediol,Stearic Acid,Xanthan Gum,Ceteareth-20,Polyacrylamide,C13-14 Isoparaffin,Laureth-7,Fragrance,Disodium EDTA,Phenoxyethanol
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROOTREE TREETHERAPY MOBIFERA HAND RELIEF
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72441-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.6 g in 30 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72441-020-02 1 in 1 CARTON 07/01/2018 1 NDC:72441-020-01 30 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2018 Labeler - KTCS Corporation (688326214) Registrant - KTCS Corporation (688326214) Establishment Name Address ID/FEI Business Operations ATEC Co., Ltd. 689276681 manufacture(72441-020)