Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6a2dea96-b06e-0f68-e053-2991aa0ad34c
Route
TOPICAL
Published
Effective Date 2018-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Stearic Acid (1.5 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-04-19

Description

Stearic Acid


Medication Information

Warnings and Precautions
  • 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.
Indications and 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.
Dosage and Administration

for external use only



Description

Stearic Acid

Section 50565-1

keep out of reach of the children



Section 51727-6

Water, Butylene Glycol, etc

Section 51945-4

Section 55105-1

Warm up pre/after-execise and after shower

Section 55106-9

Stearic Acid


Structured Label Content

Indications and Usage (34067-9)
  • 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.
Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)
  • 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.
Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Water, Butylene Glycol, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Warm up pre/after-execise and after shower

Section 55106-9 (55106-9)

Stearic Acid


Advanced Ingredient Data


Raw Label Data

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