DR. FREDS MIRACLE RUB- histamine dihydrochloride cream

Dr. Freds MIRACLE RUB by

Drug Labeling and Warnings

Dr. Freds MIRACLE RUB by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dr. Fred's MIRACLE RUB

Active Ingredients:

Histamine Dihydrochloride 0.025%

Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings:

- For external use only.
- Avoid contact with eyes.
- Do not apply to open wounds or damaged skin.

- If symptoms

persist for more than seven days, discontinue use and consult physician.

- Keep out of reach of children.

If swallowed, consult physician.

Do not use

if you have a known allergy to any of the ingredients listed.
- Do not bandage tightly.

- If pregnant or breast feeding,

contact physician prior to use.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Carbomer, C13-14 Isoparaffin, Cetearyl Olivate, Dimethyl Sulfone (MSM), Laureth-7, Magnesium Sulfate, Parfum (Fragrance), Polyacrylamide, Potassium Sorbate, Royal Jelly, Sodium Benzoate, Sodium Stearate, Sorbitan Olivate, Stearic Acid, Triethanolamine.

Manufactured for:

Haleivo, Inc.
Ojai, Ca 93023 USA
www.DrFredsMeds.com

PRINCIPAL DISPLAY PANEL

KNOCK OUT PAIN WITH
Dr. Fred's MIRACLE RUB  OJAI ORIGINAL
PATENT PENDING

4 FL. OZ. (118 ML)

Dr. Fred's MIRACLE RUB 4oz/118ml (

65121-403-25)

INGREDIENTS AND APPEARANCE

DR. FREDS MIRACLE RUB 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-403-25	1 in 1 CARTON	02/09/2017
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/06/2013

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-403)