Label: HEALFLEX RECOVERY- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72504-010-01, 72504-010-02, 72504-010-03, 72504-010-04 - Packager: Ace B&C Co.,Ltd
- 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 August 17, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Butylene Glycol Dicaprylate/Dicaprate, Beeswax, Cetearyl Alcohol, Butylene Glycol, 1,2-Hexanediol, Cetyl Alcohol, Betaine, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Propolis Wax, Caviar Extract, Centella Asiatica Extract, Asiaticoside, Asiatic Acid, Madecassic Acid, Dimethyl Sulfone, Acetyl Glucosamine, Palmitic Acid, Polysorbate 60, Sorbitan Stearate, Vanillyl Butyl Ether, Stearic Acid, Arginine, Citrus Limon (Lemon) Fruit Oil, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Cetearyl Glucoside, Carbomer, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Alcohol, Polysorbate 80, Lactic acid
- PURPOSE
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WARNINGS
Warnings:
- For external use only
- Use only as directed
- WASH HANDS THOROUGHLY AFTER USE.
- Avoid contact with eyes and sensitive areas.
- DO NOT apply on any scars or irritated areas
- Discontinue use if signs of irritation or rashes appear. If symptoms persist, consult your doctor.
- KEEP OUT OF REACH OF CHILDREN
- Keep the product away from places with high temperature, low temperature, and direct sunlight
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Directions
Directions:
- Before or after exercise and after taking a shower, apply on the shoulders, the neck, the waist, the knees, the calves, and the ankles as if massaging them.
- A proper amount for each usage is around 1g. (Almost one knuckle of the small finger)
- If sense of heating is not enough after application, then gradually use more.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEALFLEX RECOVERY
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72504-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1.6 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72504-010-02 1 in 1 CARTON 08/01/2018 1 NDC:72504-010-01 30 mL in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:72504-010-04 1 in 1 CARTON 08/01/2018 2 NDC:72504-010-03 150 mL 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 08/01/2018 Labeler - Ace B&C Co.,Ltd (694634808) Registrant - Ace B&C Co.,Ltd (694634808) Establishment Name Address ID/FEI Business Operations NEO-MEDICAL CO.,LTD 689755531 manufacture(72504-010)
