RECOVERY- stearic acid cream

RECOVERY by

Drug Labeling and Warnings

RECOVERY by is a Otc medication manufactured, distributed, or labeled by Powerful X. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Stearic Acid

INACTIVE INGREDIENT

Water, Butylene Glycol, etc

PURPOSE

Warm up pre/after-execise and after shower

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

WARNINGS

• 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

for external use only

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

RECOVERY 
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)