ROCCOS OLD SCHOOL HEALING BALM- zinc oxide cream 
Roccos Old School

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.

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Drug Facts

Active Ingredient: Purpose:

Zince Oxide 3%................................Skin Prorectant

Use:

Warnings:

For external use only-skin. Flammable. Keep away from heat and flame.

When using this product

Stop use and ask a doctor if

condition worses or does not improve.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center Immediately.

Directions

Other information

Inactive ingredients

Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea Butter) Fruit, Beeswax, Agave Americana Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannibis Sativia (Hemp) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic/Capric Triglyceride (and) Gylceryl Isostearate (and) Polyhydroxystearic Acid, and Natural Fragrance

Questions?

661-877-4280

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Roccos_Healing_Balm_30mL_label

ROCCOS OLD SCHOOL  HEALING BALM
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE.9 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SHEANUT (UNII: 84H6HBP32L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK)  
JOJOBA OIL (UNII: 724GKU717M)  
TEA TREE OIL (UNII: VIF565UC2G)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCONUT (UNII: 3RT3536DHY)  
LIME (UNII: C7X2M0VVNH)  
VERBENA HASTATA ROOT (UNII: LJ96XN173E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-010-1030 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/17/2011
Labeler - Roccos Old School (961956229)
Registrant - Creations Garden Natural Products Inc. (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products Inc.961956229manufacture

Revised: 2/2011
Document Id: fe61b4b2-3575-4817-9f7c-166f7e84d82e
Set id: 95ae368c-35ed-4c3a-a5ca-a4e09f43fc4a
Version: 1
Effective Time: 20110217
 
Roccos Old School