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NDC 54859-0202-04 Dermagesic 4; 10; 4 mg/g; mg/g; mg/g Details

Dermagesic 4; 10; 4 mg/g; mg/g; mg/g

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

Product Information

NDC	54859-0202
Product ID	54859-202_3bc1d84a-63d6-4bde-b953-2e76539339fe
Associated GPIs	90859903973720
GCN Sequence Number	076345
GCN Sequence Number Description	pramoxine/zinc oxide/calamine CREAM (G) 1-0.4-0.4% TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	41814
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	CREAM
Route	TOPICAL
Active Ingredient Strength	4; 10; 4
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Labeler Name	Llorens Pharmaceutical 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 54859-0202-04 (54859020204)

Pricing Information	N/A
NDC Package Code	54859-202-04
Billing NDC	54859020204
Package	113 g in 1 JAR (54859-202-04)
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bbff6b53-29da-45c1-8ccd-3e9df7f250e0 Details

Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Purpose

Anestheric/Analgesic

Skin Protectant

Uses

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

Warnings

For external use only. Avoid contact with the eyes

Not for Pediatric use
Hypersensitivity to "caine" anesthetics

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive Ingredients

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Questions or Comments

1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAGESIC

pramoxine hcl, zinc oxide, calamine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54859-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 mg in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-6 (UNII: 2RJS3559D3)
CETEARETH-25 (UNII: 8FA93U5T67)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54859-202-04	113 g in 1 JAR; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	04/01/2016

Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020

Document Id: 3bc1d84a-63d6-4bde-b953-2e76539339fe

Set id: bbff6b53-29da-45c1-8ccd-3e9df7f250e0

Version: 4

Effective Time: 20201223