NATURAL CREAM ARC

Manufacturer: Anjon Biologics, Inc
Effective date: 2024-04-18
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:11:28

Label at a glance#

ProductARC Skin Protectant

Active ingredientALLANTOIN

Label structure9 sections

Dosage and administration

For topical use only. Apply ARC ® twice daily to all skin areas that will be exposed to radiation, or as directed by a health care professional. Can be applied 1-2 hours prior to treatment. Massage gently into the skin until absorbed. Continue use until treatment cycle is complete. Washing of the treated area will not reduce skin protection. ARC ® does not interfere with the effectiveness of radiation treatment.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Protection Against Radiation Dermatitis

Indication for use •

INDICATIONS & USAGE SECTION

ARC^® is a pre-radiation topical cream treatment for the protection against and management of Radiation Dermatitis.

Directions •

DOSAGE & ADMINISTRATION SECTION

For topical use only. Apply ARC^® twice daily to all skin areas that will be exposed to radiation, or as directed by a health care professional. Can be applied 1-2 hours prior to treatment. Massage gently into the skin until absorbed. Continue use until treatment cycle is complete. Washing of the treated area will not reduce skin protection. ARC^® does not interfere with the effectiveness of radiation treatment.

Ingredients •

OTC - ACTIVE INGREDIENT SECTION

Each gram contains 5 mg (0.5%) Allantoin in a cream base of

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Gel, Bees Wax White, BHT, Cetyl Alcohol, DMDM H, Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Mineral Oil, Nipagin, Nipasol, Polydimethylsiloxane (PDMS), Polysorbate 60, Polysorbate 20, Sesame Oil, Shea Butter, Sorbitan Tristearate, Water

OTHER SAFETY INFORMATION

Store at room temperature. Avoid excessive heat. Do not freeze.

Warnings

WARNINGS SECTION

For external use only. Should you have an adverse reaction, consult your physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

NATURAL CREAM

THERGY

Cancer Care Solutions

Las Vegas, NV 89117
thergy.com

Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARC-001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1044541	allantoin 0.5 % Topical Ointment	PSN	6
1044541	allantoin 0.005 MG/MG Topical Ointment	SCD	6
1044541	allantoin 0.5 % Topical Stick	SY	6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69148-001-00	2024-04-24	C162847	48780-1	1030e365-5910-111a-e063-dadaa90a10e2	NATURAL CREAM ARC
69148-001-01	2024-04-24	C162847	48780-1	1030e365-5910-111a-e063-dadaa90a10e2	NATURAL CREAM ARC
69148-001-00	2024-01-30	C162847	48780-1	1030e365-5910-111a-e063-dadaa90a10e2	NATURAL CREAM ARC
69148-001-01	2024-01-30	C162847	48780-1	1030e365-5910-111a-e063-dadaa90a10e2	NATURAL CREAM ARC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69148-001-00	ARC Skin Protectant	118.6 g in 1 TUBE	OINTMENT	118.6	6
69148-001-01	ARC Skin Protectant	60 g in 1 TUBE	OINTMENT	60	6
69148-001-02	ARC Skin Protectant	100 g in 1 TUBE	OINTMENT	100	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69148-001	ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]	6	Current NDC, Legacy NDC, 3 package rows	20240426_f4ff79dd-cb38-4cca-9631-a2758a171873.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	1
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SORBITAN TRISTEARATE	INACTIVE INGREDIENT	6LUM696811	1
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

ARC Skin Protectant
ALLANTOIN
ALOE VERA LEAF
WHITE WAX
BUTYLATED HYDROXYTOLUENE
CETYL ALCOHOL
DMDM HYDANTOIN
GLYCERIN
GLYCERYL STEARATE SE
ISOPROPYL MYRISTATE
MINERAL OIL
METHYLPARABEN SODIUM
PROPYLPARABEN
DIMETHICONE
POLYSORBATE 60
POLYSORBATE 20
SESAME OIL
SHEA BUTTER
SORBITAN TRISTEARATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69148-001	69148-001-00, 69148-001-01, 69148-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
WHITE WAX	7G1J5DA97F	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
MINERAL OIL	T5L8T28FGP	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIMETHICONE	92RU3N3Y1O	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SESAME OIL	QX10HYY4QV	IACT
SHEA BUTTER	K49155WL9Y	IACT
SORBITAN TRISTEARATE	6LUM696811	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii+route 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	LOTION / TOPICAL		228 mg	Exact identifier — unii+route 12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii+route 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii+route 4 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii+route 4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii+route 8 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	LOTION / TOPICAL		228 mg	Exact identifier — unii+route 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii+route 8 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii+route 8 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii+route 8 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii+route 8 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii+route 8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii+route 8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii+route 12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier ndc (package): 69148-001-02 ndc (package): 69148-001-01 ndc (package): 69148-001-00 ndc (product): 69148-001 ndc11 (package): 69148000102 ndc11 (package): 69148000101 ndc11 (package): 69148000100 spl id: 8b450573-d048-4077-8c0b-9e0a2e8a72c2 spl set id: f4ff79dd-cb38-4cca-9631-a2758a171873

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.