HYDRAHEAL FOOT CREAM- glycerin and vitamin e foot cream liniment 
Shenzhen XiaoMai Manufacturing Co., Ltd.

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.

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Active ingredients



Tea Tree Oil - 5%
Honey - 3%
Urea - 10%


PURPOSE


Designed to provide deep hydration and soothing relief, it helps maintain soft and moisturized foot skin while alleviating dryness, roughness, and foot fatigue.


Uses


Apply the foot cream evenly onto clean feet, gently massage with fingertips, paying special attention to dry or rough areas. It is recommended for daily use, especially before bedtime, to maintain soft and moisturized foot skin and alleviate dryness, roughness, and foot fatigue.

Warning

For external use only

not use


On damaged or broken skin.


When using this product


keep out of eyes. Rinse with water to remove.


Stop use and ask a doctor


Discontinue use immediately if you experience severe discomfort and
seek medical attention promptly.


Keep out of reach of children.


If swallowed, get medical help or contact a Poison Control Center right away.

Directions


Apply the foot cream evenly onto clean feet, gently massage with fingertips, paying special attention to dry or rough areas. It is recommended for daily use, especially before bedtime, to maintain soft and moisturized foot skin and alleviate dryness, roughness, and foot fatigue.

Inactive ingredients


Water - 66.5%
Glycerin - 10%
Glyceryl Stearate - 0.5%
Propylene Glycol - 2%
Cetearyl Alcohol - 2%
Vitamin E - 0.5%
Pro-Vitamin B5 - 0.5%

Other information


Store in a cool and dry place to maintain product quality. Avoid exposure to direct sunlight and high temperatures. Ensure the container is kept tightly sealed.

label

HYDRAHEAL FOOT CREAM 
glycerin and vitamin e foot cream liniment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL5 g  in 100 mL
HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH) HONEY3 g  in 100 mL
1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA (UNII: 0214C2T14J) (HONEY - UNII:Y9H1V576FH) 1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83872-017-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/07/2024
Labeler - Shenzhen XiaoMai Manufacturing Co., Ltd. (712999147)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen XiaoMai Manufacturing Co., Ltd.712999147manufacture(83872-017)

Revised: 2/2024
Document Id: 10c22a55-fe90-608c-e063-6294a90a1ceb
Set id: 10c22a55-fe8f-608c-e063-6294a90a1ceb
Version: 1
Effective Time: 20240206
 
Shenzhen XiaoMai Manufacturing Co., Ltd.