Spalife Soft As Heel Oil-Gel smoothing Heel Patch by YIWU HAODING MEDICAL CO.,LTD

Spalife Soft As Heel Oil-Gel smoothing Heel Patch by

Drug Labeling and Warnings

Spalife Soft As Heel Oil-Gel smoothing Heel Patch by is a Otc medication manufactured, distributed, or labeled by YIWU HAODING MEDICAL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPALIFE SOFT AS HEEL OIL-GEL SMOOTHING HEEL PATCH- salicylic acid swab 
YIWU HAODING MEDICAL CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Salicylic acid  3%

Purpose

soft heel

Use

soft heel

Warnings

For external use only.

Use only as directed. If contact with the eyes occurs, rinse with cold water.

Not for consumptiohn

Do not use if pregnant or nursing.

If you are diabetic, consult with your physician before use.

Discontinue use if signs Of irriation develop.

if swallowed, get medical help or contact Poison control Center right away.

do not use

Do not use if you are gregnant.

Discontinue use if signs Of irriation develop.

Directions

• Wash and dry feet
• Peel off outer liner and release paper.
• Place patch against heel, round edge on top.
• Wrap heel with both sides of patch, smoothing edges down firmly
• Leave on for 6-7 hours.
• Remove & Discard (one-time use only). No need to rinse!

Inactive Ingredient

water, Glycerol, Trehalose, Propylene Glycol, Castor Oil, Lavenderessential Oil, CMC, Sodium Lactate, Hydroxyaluminum,Sodium Polyacrylate, Phenoxyethanol

SPALIFE SOFT AS HEEL OIL-GEL SMOOTHING HEEL PATCH 
salicylic acid swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69139-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TREHALOSE (UNII: B8WCK70T7I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69139-600-01	1 in 1 PACKAGE	03/13/2023	03/15/2023
1		2.4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/13/2023	03/15/2023

Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384)

Establishment
Name	Address	ID/FEI	Business Operations
YIWU HAODING MEDICAL CO.,LTD		421362384	manufacture(69139-600)

Revised: 3/2023

Document Id: ca25a4b5-db69-4de4-8451-aa02b0ba669f

34390-5

Set id: 674a42a3-38ea-4bb1-87ab-ae3b228dd6a1

Version: 10

Effective Time: 20230315