Label: RECOVERY- stearic acid cream
70042-0002-4, view more70042-0002-5, 70042-0002-6
- 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.
Updated January 7, 2021
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- Avoid to touch your face and eye. (Avoid to let the cream to make contacts with your face and eyes.) If the situcation happens, flush the part with water for 15 minutes.
- Do not apply to wounds or damaged skin.
- When a pain caused by the cream continues for more than 10 days, or a redness/irritation happens, or any situation happens to children under 12-year-old, please consult a physician immediately.
- DOSAGE & ADMINISTRATION
INDICATIONS & USAGE
- Use Pre- Activity: Put on the FlexPower recovery cream and massage your body parts for 10 minutes to warm up before doing exercises. No matter what purpose of the workout is, applyting FlexPower can help to warm-up your body and deliver a better time of exercising.
- Use After-Activty: After Applied- Use the FlexPower recovery cream as a lotion and massage when applying for warm-sensation after shower. Wash your hand with soap after application.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
stearic acid cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70042-0002 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:70042-0002-1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/19/2018 2 NDC:70042-0002-2 250 mL in 1 TUBE; Type 0: Not a Combination Product 04/19/2018 3 NDC:70042-0002-3 100 mL in 1 TUBE; Type 0: Not a Combination Product 04/19/2018 4 NDC:70042-0002-4 60 mL in 1 TUBE; Type 0: Not a Combination Product 04/19/2018 5 NDC:70042-0002-5 30 mL in 1 TUBE; Type 0: Not a Combination Product 04/19/2018 6 NDC:70042-0002-6 2 mL in 1 JAR; Type 0: Not a Combination Product 04/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/19/2018 Labeler - Powerful X (689515038) Registrant - Powerful X (689515038) Establishment Name Address ID/FEI Business Operations Powerful X 689515038 manufacture(70042-0002) , label(70042-0002) , pack(70042-0002)