Keralyt (Page 2 of 2)

ADVERSE REACTIONS

Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE

See WARNINGS

DOSAGE AND ADMINISTRATION

The preferable method of use is to apply KERALYT GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of KERALYT GEL will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.

HOW SUPPLIED

40 g Plastic bottle NDC 54868-1400-0

Store at controlled room temperature 59° to 86° F (15° to 30° C)

REFERENCES

  1. Davies M, Marks R: Br J Dermatol 95: 187-192,1976.
  2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.
  3. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.
  4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975.
  5. Goldsmith LA: Int J Dermatol 18: 32-36.
  6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

SUMMERS
LABORATORIES INC

Manufactured by:
EMS Contract Packaging, Hatfield, PA 19440
Distributed by:
Summers Laboratories, Inc. Collegeville, PA 19426
1-800-533-SKIN (7546) • www.sumlab.com
KERALYT is a trademark of Summers Laboratories, Inc.

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

KERALYT® Gel

40 g

image of package label
(click image for full-size original)
KERALYT salicylic acid gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1400(NDC:11086-030)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
HYDROXYPROPYL CELLULOSE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1400-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 40 g in 1 TUBE This package is contained within the CARTON (54868-1400-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/10/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2011 Physicians Total Care, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.