ARC SKIN PROTECTANT- allantoin ointment

ARC Skin Protectant by

Drug Labeling and Warnings

ARC Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Anjon Biologics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARC Skin Protectant Ointment

Active Ingredient / Purpose

Allantoin 0.5% .............................. Skin Protectant

Use

• temporarily protects minor burns
  

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• your skin shows significant sign of irritation or discomfort

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed

Other information

• Keep in a cool place or out of direct sunlight
  

Inactive Ingredients

aloe vera leaf gel, benzoic acid, benzyl alcohol, cetyl alcohol, citric acid, coconut oil, glycenn, imidazolidinyl urea, isopropyl mylistate, jojoba seed oil, methylisothiazolinone, mineral water, shea butter, sorbitan histearate, vitamin A, vitamin E acetate

Questions or comments?

USA 1-855-434-0300

ARC Skin Protectant Ointment 4oz/118.6g (

69148-001-00)

ALL NATURAL CREAM

ARC

Protection for Radiation Dermatitis

INGREDIENTS AND APPEARANCE

ARC SKIN PROTECTANT 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69148-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
IMIDUREA (UNII: M629807ATL)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JOJOBA OIL (UNII: 724GKU717M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
VITAMIN A (UNII: 81G40H8B0T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69148-001-00	118.6 g in 1 TUBE; Type 0: Not a Combination Product	08/06/2014
2	NDC: 69148-001-01	60 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/06/2014

Labeler - Anjon Biologics, Inc (054126951)

Establishment
Name	Address	ID/FEI	Business Operations
Anjon Biologics, Inc		054126951	manufacture(69148-001)