Label: ZENOL POWERFULX RECOVERYCREAM- stearic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70042-0001-1, 70042-0001-2, 70042-0001-3, 70042-0001-4, view more70042-0001-5 - Packager: Powerful X
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children - DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZENOL POWERFULX RECOVERYCREAM
stearic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70042-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID 1.5 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:70042-0001-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 02/02/2018 2 NDC:70042-0001-2 60 mL in 1 TUBE; Type 0: Not a Combination Product 02/02/2018 3 NDC:70042-0001-3 100 mL in 1 TUBE; Type 0: Not a Combination Product 02/02/2018 4 NDC:70042-0001-4 250 mL in 1 TUBE; Type 0: Not a Combination Product 02/02/2018 5 NDC:70042-0001-5 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/02/2018 Labeler - Powerful X (689515038) Registrant - Powerful X (689515038) Establishment Name Address ID/FEI Business Operations Powerful X 689515038 manufacture(70042-0001) , label(70042-0001) , pack(70042-0001)
