Body Repair Balm

Manufacturer: Skinfix, Inc. | Product Integrity Laboratory, LLC | Canadian Custom Packaging Company
Effective date: 2015-01-11
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-02 01:34:04

Label at a glance#

ProductBody Repair Balm

Active ingredientOATMEAL

Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to . eczema . rash . dermatitis

Dosage and administration

Apply balm liberally as needed, especially after bathing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to . eczema . rash . dermatitis

Warnings

WARNINGS SECTION

For external use only

When using this product -

OTC - WHEN USING SECTION

Avoid contact with eyes

Stop use and ask a doctor if -

OTC - ASK DOCTOR SECTION

- condition worsens - symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply balm liberally as needed, especially after bathing.

Other information

OTHER SAFETY INFORMATION

- Store at 65 - 80F - May stain fabrics - For adults and children two year of age and older

Inactive Ingredients

INACTIVE INGREDIENT SECTION

allantoin, aloe barbadensis leaf juice, beeswax, butyrospermum parkii (shea butter), glycine soja (soybean) oil, liquidambar orientalis (styrax), myroxylon balsumum (balsam tolu), paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, styrax benzoin resin extract (benzoin), tocopherol, zinc oxide

Package Label Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skinfix

Body Repair Balm

Treats eczema, dryness, dermatitis

Image components

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61328-009-03	2020-11-20	C162847	48780-1	9d75b9d0-8683-f424-e053-dadaa90a57ce	Body Repair Balm
61328-009-03	2020-01-31	C162847	48780-1	9d75b9d0-8683-f424-e053-dadaa90a57ce	Body Repair Balm

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	7
OATMEAL	ACTIVE MOIETY	8PI54V663Y	7
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	7
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	7
ALOE	INACTIVE INGREDIENT	V5VD430YW9	7
BENZOIN RESIN	INACTIVE INGREDIENT	GK21SBA74R	7
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	7
LIQUIDAMBAR ORIENTALIS RESIN	INACTIVE INGREDIENT	63V91G4W93	7
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	7
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	7
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	7
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	7
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	7
TOLU BALSAM	INACTIVE INGREDIENT	TD2LE91MBE	7
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	7
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	7

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Body Repair Balm
Oatmeal
ZINC OXIDE
PETROLATUM
SOYBEAN OIL
JOJOBA OIL
SHEA BUTTER
ALMOND OIL
TOCOPHEROL
WHITE WAX
PARAFFIN
ALLANTOIN
BENZOIN RESIN
LIQUIDAMBAR ORIENTALIS RESIN
TOLU BALSAM
ALOE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61328-009	61328-009-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	IACT
PETROLATUM	4T6H12BN9U	IACT
SOYBEAN OIL	241ATL177A	IACT
JOJOBA OIL	724GKU717M	IACT
SHEA BUTTER	K49155WL9Y	IACT
ALMOND OIL	66YXD4DKO9	IACT
TOCOPHEROL	R0ZB2556P8	IACT
WHITE WAX	7G1J5DA97F	IACT
PARAFFIN	I9O0E3H2ZE	IACT
ALLANTOIN	344S277G0Z	IACT
BENZOIN RESIN	GK21SBA74R	IACT
LIQUIDAMBAR ORIENTALIS RESIN	63V91G4W93	IACT
TOLU BALSAM	TD2LE91MBE	IACT
ALOE	V5VD430YW9	IACT
OATMEAL	8PI54V663Y	ACTIB

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 · 66 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZOIN RESIN	BENZOIN RESIN	GK21SBA74R	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	AEROSOL, FOAM / TOPICAL	50 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	SUPPOSITORY / RECTAL	265 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALMOND OIL	ALMOND OIL	66YXD4DKO9	CREAM / TOPICAL	2 %w/w		Exact identifier — unii candidate
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		223 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	SOLUTION / TOPICAL	5.82 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, EMULSION / INTRAVENOUS		107100 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	CAPSULE / ORAL		1318 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 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
903a08ad-d08a-4c95-a814-83e280fb3302			58dfcf5e-d7b0-488f-a215-3e76b03c6b98	2020-11-20	Warnings	Exact identifier spl set id: 58dfcf5e-d7b0-488f-a215-3e76b03c6b98

Reported adverse events (FAERS/openFDA)#

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