Search by Drug Name or NDC

NDC 54859-0120-04 Dermagesic .4; 1; .4 mg/100mL; mg/100mL; mg/100mL Details

Dermagesic .4; 1; .4 mg/100mL; mg/100mL; mg/100mL

Dermagesic is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceuticals International Division. The primary component is FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE.

Product Information

NDC	54859-0120
Product ID	54859-120_bdc7538b-60af-4dce-b072-ad2a91cb7716
Associated GPIs	90859903970920
GCN Sequence Number	076346
GCN Sequence Number Description	pramoxine/zinc oxide/calamine LOTION 1-0.4-0.4% TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	41815
HICL Sequence Number	043598
HICL Sequence Number Description	PRAMOXINE HCL/ZINC OXIDE/CALAMINE
Brand/Generic	Brand
Proprietary Name	Dermagesic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pramoxine HCl, Zinc Oxide, Calamine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	.4; 1; .4
Active Ingredient Units	mg/100mL; mg/100mL; mg/100mL
Substance Name	FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Labeler Name	Llorens Pharmaceuticals International Division
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54859-0120-04 (54859012004)

Pricing Information	N/A
NDC Package Code	54859-120-04
Billing NDC	54859012004
Package	118 mL in 1 BOTTLE (54859-120-04)
Marketing Start Date	2014-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8b3f8894-1ed7-4888-a42c-8510d6161edd Details

SPL UNCLASSIFIED SECTION

Active Ingredients Purpose

Pramozine HCl .... 1% ............ Anesthetic/Analgesic

Zinc Oxide .........0.4% ............ Skin Protectant

Calamine ...........0.4% ............ Skin Protectant

SPL UNCLASSIFIED SECTION

Purpose

Anesthetic/Analgesic

Skin Protectant

SPL UNCLASSIFIED SECTION

Uses

for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
dries the oozing and weeping of poison ivy, poison oak and poison sumac.

SPL UNCLASSIFIED SECTION

Warnings

For external use only. Avoid contact with the eyes
Not for Pediatric use
Hypersensitivity to "caine" anesthetics

SPL UNCLASSIFIED SECTION

Do not use

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

on chicken pox
on measles

Stop use and ask a doctor if condition worsens or does not improve within 7 days

symptoms persist for more than 7 days or clear up and occur again within a few days

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions SHAKE WELL

Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
Children under 2 years of age ask a doctor
Do not use more often than directed

SPL UNCLASSIFIED SECTION

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

SPL UNCLASSIFIED SECTION

Questions: 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAGESIC

pramoxine hcl, zinc oxide, calamine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54859-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.4 mg in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.4 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54859-120-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	01/01/2014

Labeler - Llorens Pharmaceuticals International Division (037342305)

Revised: 12/2020

Document Id: bdc7538b-60af-4dce-b072-ad2a91cb7716

Set id: 8b3f8894-1ed7-4888-a42c-8510d6161edd

Version: 2

Effective Time: 20201223

Search by Drug Name or NDC

NDC 54859-0120-04 Dermagesic .4; 1; .4 mg/100mL; mg/100mL; mg/100mL Details

Dermagesic .4; 1; .4 mg/100mL; mg/100mL; mg/100mL

Product Information

Package

Package Images

NDC 54859-0120-04 (54859012004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8b3f8894-1ed7-4888-a42c-8510d6161edd Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?