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General product information only, not medical advice. For skin that is broken, inflamed or reacting, or for any question about a specific person, ask a clinician.
Short answer
A skin adhesive remover is a liquid, spray or wipe product made to dissolve medical tape, dressing or appliance adhesive from the skin. In the United States, FDA lists adhesive tape solvents as Class I devices under product code KOX and 21 CFR 878.4730, exempt from 510(k) premarket notification but still subject to general controls. The same regulation also covers surgical skin degreasers.
Definition and scope
The regulation, 21 CFR 878.4730, is titled “Surgical skin degreaser or adhesive tape solvent”. It describes a device that consists of a liquid intended to dissolve surface skin oil or adhesive tape, and it names legacy solvents such as 1,1,1-trichloroethane as examples of the liquid. The examples show the age of the rule (first issued in 1988, amended 1994 and 2001); they do not describe what any particular product contains today, so the ingredient list on the product itself is the thing to read.
FDA’s classification database lists product code KOX as “Solvent, Adhesive Tape”: device class 1, regulation number 878.4730, review panel General and Plastic Surgery, with 12 premarket notification records on file (checked 2026-11-01). Everyday names for the same product family include medical adhesive remover, tape remover and adhesive tape solvent. This guide is about general skin adhesive removers; ostomy adhesives and their removers have their own guide, and medical tape is covered separately.
How removers are regulated and labelled in practice
Class I means general controls apply. Exemption from 510(k) means a maker does not file a premarket notification for a product that fits the regulation, subject to the limits in 21 CFR 878.9; it does not mean the product is outside FDA’s device rules.
One public record shows what a labelled product looks like in FDA’s device identification database. The AccessGUDID record for a 4 oz adhesive remover from Chemence Medical (checked 2026-11-01, used only as an example of a record, not as a recommendation) lists:
- GMDN term: “Patient medical adhesive remover” (code 60494), defined as a liquid solvent intended for removal of medical adhesive or adhered devices, such as residual adhesive, adhesive tape and ostomy devices, from a patient’s skin, and not reusable after application.
- FDA product code: KOX, Solvent, Adhesive Tape.
- Single use: yes. Labelled sterile: yes. Over the counter: yes. Premarket submission: exempt.
Types and related terms
The same job is sold under different regulatory identities, which is the main source of confusion when comparing records.
| Name you may see | FDA product code and regulation | Source |
|---|---|---|
| Adhesive tape solvent (“Solvent, Adhesive Tape”) | KOX, 21 CFR 878.4730, Class I | openFDA classification API; 21 CFR 878.4730 |
| Surgical skin degreaser (“Degreaser, Skin, Surgical”) | KOY, 21 CFR 878.4730, Class I | openFDA classification API |
| Ostomy collector (“Collector, Ostomy”), a code under which some ostomy-brand removers are listed | EXB, 21 CFR 876.5900, Class I | openFDA classification API |
Medical adhesive remover
This is the everyday phrase for the product family above; in the device identification database the matching term is “Patient medical adhesive remover”.
Tape residue and sticky residue on skin
These describe the problem rather than a product type. The PrescQIPP bulletin on adhesive removers (March 2018, England and Wales) describes removers as designed to ease non-traumatic removal of adhesive dressings and appliances and to remove residue. The same bulletin notes there are no randomised trials of these products and the evidence is limited. The directions on a product’s own label, not a general guide, govern how it is used.
Where it matters for labs, clinics and supply decisions
Three records can be compared across products that look alike, each drawn from a source described above:
- Product code. KOX, KOY and EXB are different FDA classifications; two removers that look alike can sit under different codes.
- Device identification record. The GMDN term, single-use flag, sterile flag and premarket status are public fields on an AccessGUDID record.
- Ingredients. The regulation’s solvent examples are legacy chemistries and PrescQIPP notes that ingredients differ by product, so the ingredient list is read per product.
Common misunderstandings
- “Exempt means unregulated.” The exemption is from 510(k) premarket notification only; general controls still apply.
- “The regulation lists what is in today’s products.” Its solvent examples are legacy chemistries named in a 1988 rule.
- “Every remover is an ostomy product.” Some are listed under the ostomy code EXB, but the tape solvent code KOX is a separate classification.
FAQ
What is a medical adhesive remover?
A liquid solvent product intended to remove medical adhesive or adhered devices from a patient’s skin (GMDN code 60494). FDA classifies adhesive tape solvents as Class I devices under 21 CFR 878.4730.
How do I remove medical tape residue from skin?
Follow the directions on the product’s own label or instructions for use; this guide gives no step list and is not medical advice. A clinician can advise on skin that is sore, broken or reacting. See also the guide on reactions to medical tape.
How do I remove sticky residue from skin?
PrescQIPP describes adhesive removers as intended to remove residue as well as the dressing or appliance; use the product’s label directions. Ostomy-specific removers are covered in the ostomy adhesives guide.
Sources
All sources below were checked on 2026-11-01.
- FDA, openFDA device classification API, product codes KOX, KOY and EXB: https://api.fda.gov/device/classification.json?search=product_code:KOX; openFDA 510(k) API for KOX (12 records): https://api.fda.gov/device/510k.json?search=product_code:KOX
- 21 CFR 878.4730, Surgical skin degreaser or adhesive tape solvent: https://www.law.cornell.edu/cfr/text/21/878.4730; 53 FR 23872 (June 24, 1988), amended 59 FR 63010 (1994) and 66 FR 38803 (2001).
- NLM AccessGUDID, device record 00854137001726: https://accessgudid.nlm.nih.gov/devices/00854137001726
- PrescQIPP Bulletin B189, Stoma and continence: Adhesive removers, March 2018 v2.0 (England and Wales): https://www.prescqipp.info/
