Rough Dry (Zinc Oxide, Salicylic Acid Cream) Cream [Kelada Creative Group Llc Dba Salve] -

ROUGH DRY (ZINC OXIDE, SALICYLIC ACID CREAM) CREAM [KELADA CREATIVE GROUP LLC DBA SALVE]
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NDC	71157-0020-1
Set ID	451ec259-f493-206a-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	Kelada Creative Group LLC DBA SALVE
Generic Name
Product Class
Product Number
Application Number	PART347

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Kelada Creative Group LLC DBA SALVE (014340121)

Registrant - Kelada Creative Group LLC DBA SALVE (014340121)

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

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