SHUR CLENS SKIN WOUND CLEANSER 24 COUNT SINGLE DOSE AMPULES- poloxamer 188 liquid
ConvaTec Inc

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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Shur-Clens Skin Wound Cleanser 24 Count Single Dose Ampules

Drug Facts

Active Ingredient (in each 20ml)

Poloxamer 188 (20%)

Purpose

Skin Wound Cleanser

Uses

• Aids in the removal of foreign materials such as dirt and debris
• To clean superficial wounds

Warnings

• For external use only • This product is not for use on wild or domestic animal bites. If you have an animal bite, consult your physician immediately • Do not use this product for more than 10 days. If condition worsens or persists, see your physician • Do not bandage tightly

Keep out of reach of children

Directions

• Twist off sealed tab
• Apply contents directly to the area to be cleansed
• Contents may be poured onto an Optipore® Wound Cleansing Sponge or sterile gauze pad, then gently cleanse

Other Information

• Do not use if sealed tab is broken or missing
• Not for injection
• This product contains no antimicrobial ingredients

Inactive Ingredient:

Purified Water

Package Labeling:

Label

SHUR CLENS SKIN WOUND CLEANSER 24 COUNT SINGLE DOSE AMPULES
poloxamer 188 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43553-0000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLOXAMER 188 (UNII: LQA7B6G8JG) (POLOXAMER 188 - UNII:LQA7B6G8JG)	POLOXAMER 188	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43553-0000-0	24 in 1 CARTON	10/26/2017
1		20 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/26/2017

Labeler - ConvaTec Inc (080128290)