HAVASU HEMP CREAM Soothing Pain Relief Rub

HAVASU HEMP Soothing Pain Relief Rub by

Drug Labeling and Warnings

HAVASU HEMP Soothing Pain Relief Rub by is a Otc medication manufactured, distributed, or labeled by Havasu Nutrition LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAVASU HEMP SOOTHING PAIN RELIEF RUB- histamine dihydrochloride cream 
Havasu Nutrition LLC

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HAVASU HEMP CREAM Soothing Pain Relief Rub

Drug Facts:

Active Ingredient

Histamine DHCl 0.03%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises and sprains.

Warnings:

• For external use only.

Do not

• apply to wounds or damaged skin.
• bandage tightly.

When using this product

• avoid contact with eyes.

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

If pregnant or breast feeding,

ask a health professional before use.

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a doctor.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, **Cannabis Sativa (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Gluconolactone, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sorbitan Olivate, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

HAVASU HEMP SOOTHING PAIN RELIEF RUB 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79216-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79216-159-01	1 in 1 BOX	05/01/2020	01/01/2023
1		118 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/01/2020	01/01/2023

Labeler - Havasu Nutrition LLC (107874529)

Revised: 12/2024

Document Id: 29217eeb-64ff-db8f-e063-6394a90a7e86

34390-5

Set id: 2bd93522-4b25-4500-822a-b54676a03d40

Version: 4

Effective Time: 20241213