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Rough Dry

Dosage form: cream
Ingredients: ZINC OXIDE 8g in 90mL
Labeler: Kelada Creative Group LLC DBA SALVE
NDC Code: 71157-0020

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rough/Dry

Zinc oxide 1.1%

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


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

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

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

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

ROUGH DRY 
zinc oxide, salicylic acid cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71157-0020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE8 g  in 90 mL
Inactive Ingredients
Ingredient NameStrength
SALICYLIC ACID15 g  in 90 mL
WHITE WAX 
COCOA BUTTER 
ROSEMARY OIL 
PATCHOULI OIL 
BERGAMOT OIL 
MEADOWFOAM SEED OIL 
ALMOND 
AVOCADO OIL 
HYDROGENATED MACADAMIA SEED OIL 
Packaging
#Item CodePackage Description
1NDC:71157-0020-190 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/09/2017
Labeler - Kelada Creative Group LLC DBA SALVE (014340121)
Registrant - Kelada Creative Group LLC DBA SALVE (014340121)
Establishment
NameAddressID/FEIOperations
Kelada Creative Group LLC DBA SALVE014340121manufacture(71157-0020)

Revised: 10/2017
 
Kelada Creative Group LLC DBA SALVE

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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