ROCCOS OLD SCHOOL HEALING BALM- zinc oxide cream

Roccos Old School by

Drug Labeling and Warnings

Roccos Old School by is a Otc medication manufactured, distributed, or labeled by Roccos Old School, Creations Garden Natural Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient: Purpose:

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

Use:

• To promote healing of minor skin irritations and sunburn.

Warnings:

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

When using this product

• Avoid contact with the eyes. In case of contact with eyes, flush thoroughly with water.

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

• Apply balm liberally as often as necessary.

Other information

• Store at controlled room temperature.
• Do not store above 105°F.

  
  

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ROCCOS OLD SCHOOL  HEALING BALM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.9 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-010-10	30 mL in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/17/2011

Labeler - Roccos Old School (961956229)

Registrant - Creations Garden Natural Products Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products Inc.		961956229	manufacture