ROUGH DRY- zinc oxide, salicylic acid cream cream

Rough Dry by

Drug Labeling and Warnings

Rough Dry by is a Otc medication manufactured, distributed, or labeled by Kelada Creative Group LLC DBA SALVE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc oxide 1.1%

PURPOSE

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

WARNINGS

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

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

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.

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROUGH DRY 
zinc oxide, salicylic acid cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71157-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ)	15 g  in 90 mL
WHITE WAX (UNII: 7G1J5DA97F)
COCOA BUTTER (UNII: 512OYT1CRR)
ROSEMARY OIL (UNII: 8LGU7VM393)
PATCHOULI OIL (UNII: F3IN55X5PO)
BERGAMOT OIL (UNII: 39W1PKE3JI)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ALMOND (UNII: 3Z252A2K9G)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYDROGENATED MACADAMIA SEED OIL (UNII: W4FFC8IM2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71157-0020-1	90 mL in 1 CAN; Type 0: Not a Combination Product	01/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/09/2017

Labeler - Kelada Creative Group LLC DBA SALVE (014340121)

Registrant - Kelada Creative Group LLC DBA SALVE (014340121)

Establishment
Name	Address	ID/FEI	Business Operations
Kelada Creative Group LLC DBA SALVE		014340121	manufacture(71157-0020)