Rough Dry

Manufacturer: Kelada Creative Group LLC DBA SALVE
Effective date: 2017-10-16
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:52:42

Label at a glance#

ProductRough Dry

Active ingredientZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 1.1%

OTC - PURPOSE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.

WARNINGS SECTION

For external use only

Do not use other than as directed

When using this product

avoid contact with eyes and mucous membranes
do not apply to wounds or bleeding skin

DOSAGE & ADMINISTRATION SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Salicylic acid, Macadamia nut butter, Sweet almond butter, Meadowfoam seed oil, Organic avocado oil, Beeswax, Cocoa butter, Bergamot essential oil, Patchouli essential oil, Rosemary essential oil

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rough Dry

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0013189018261	GTIN-13: 0013189018261 EAN-13: 0013189018261 GTIN-12: 013189018261 UPC-A: 013189018261 GTIN storage (14 digits): 00013189018261	Rough Dry.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71157-0020-1	2020-01-31	C162847	48780-1	9d75b9d0-8d19-f424-e053-dadaa90a57ce	Rough/Dry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71157-0020-1	Rough Dry	90 mL in 1 CAN	CREAM	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71157-0020	ROUGH DRY (ZINC OXIDE, SALICYLIC ACID CREAM) CREAM [KELADA CREATIVE GROUP LLC DBA SALVE]	3	Legacy NDC, 1 package rows	20171016_451ec259-f493-206a-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Rough Dry
zinc oxide, salicylic acid cream
ZINC OXIDE
SALICYLIC ACID
WHITE WAX
COCOA BUTTER
ROSEMARY OIL
PATCHOULI OIL
BERGAMOT OIL
MEADOWFOAM SEED OIL
ALMOND
AVOCADO OIL
HYDROGENATED MACADAMIA SEED OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71157-0020	71157-0020-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
SALICYLIC ACID	O414PZ4LPZ	IACT
WHITE WAX	7G1J5DA97F	IACT
COCOA BUTTER	512OYT1CRR	IACT
ROSEMARY OIL	8LGU7VM393	IACT
PATCHOULI OIL	F3IN55X5PO	IACT
BERGAMOT OIL	39W1PKE3JI	IACT
MEADOWFOAM SEED OIL	412ZHA4T4Y	IACT
ALMOND	3Z252A2K9G	IACT
AVOCADO OIL	6VNO72PFC1	IACT
HYDROGENATED MACADAMIA SEED OIL	W4FFC8IM2K	IACT

Source Document#

Source XML · Source PDF

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
5ba9e482-8fa6-8267-e053-2a91aa0a80d3			451ec259-f493-206a-e054-00144ff88e88	2017-10-16	Warnings	Exact identifier spl id: 5ba9e482-8fa6-8267-e053-2a91aa0a80d3 spl set id: 451ec259-f493-206a-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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