Complete hemp by Complete Hemp, LLC

Complete hemp by

Drug Labeling and Warnings

Complete hemp by is a Otc medication manufactured, distributed, or labeled by Complete Hemp, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPLETE HEMP- oatmeal, zinc oxide cream 
Complete Hemp, LLC

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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Active Ingredients

Colloidal Oatmeal 2%

Zinc Oxide 6%

Purpose

Skin Protectant

Use

Temporarily protects and helps relieve minor skin irritation due to: Burns Insect bites Eczema Psoriasis Dermatitis

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

This product contains cannabinoids, including but not limited to THC, under 0.3%. If you are drug tested for any reason, please consult your testing party prior to use.

If you are allergic to any ingredients listed or are pregnant or breastfeeding, consult your physician prior to use.

If irritation occurs, discontinue use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults Only: Apply generously to the affected area. Gently massage in a circular motion. Use twice daily, or as needed.
F or Children: Consult physician.

Other information

• Shake well before use. First, prime the airless bottle by pumping the top until it dispenses the product.
• DO NOT puncture the self sealing membrane.
• Store in a cool, dark, dry place.

Inactive ingredients

Aloe Vera*, Shea Butter*, Olive Oil*, Cetyl Alcohol (Coconut Derived), Vegetable Glycerin*, Witch Hazel*, Full Spectrum (Cannabis Sativa) [aerial plant parts] Oil Extract, MSM, Licorice*, Chamomile, Comfrey, Coconut Extract*, Frankincense*, Vitamin E, Clove Oil*

*ORGANIC

Questions or Comments?: Call 888-901-6150 or visit www.completehemp.com

Package Label - Principal Display Panel

COMPLETE HEMP 
oatmeal, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79551-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
SHEA BUTTER (UNII: K49155WL9Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
HEMP (UNII: TD1MUT01Q7)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
LICORICE (UNII: 61ZBX54883)
CHAMOMILE (UNII: FGL3685T2X)
COMFREY (UNII: D05HXK6R3G)
COCONUT (UNII: 3RT3536DHY)
FRANKINCENSE (UNII: R9XLF1R1WM)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79551-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2020	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/15/2020	04/15/2020

Labeler - Complete Hemp, LLC (117572790)

Establishment
Name	Address	ID/FEI	Business Operations
CHOICE ALL NATURAL INC D		103340792	manufacture(79551-001)

Revised: 7/2022

Document Id: e38b50ba-3386-861d-e053-2995a90a10f2

34390-5

Set id: 87ca0842-c2ed-439d-ba47-e5b4fd64b155

Version: 3

Effective Time: 20220711