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DR. FREDS MIRACLE RUB (histamine dihydrochloride) cream
[Pure Source Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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)

Label

INGREDIENTS & APPEARANCE

DR. FREDS MIRACLE RUB  
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65121-403
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
C13-14 ISOPARAFFIN 
CETEARYL OLIVATE 
DIMETHYL SULFONE 
LAURETH-7 
MAGNESIUM SULFATE 
POTASSIUM SORBATE 
ROYAL JELLY 
SODIUM BENZOATE 
SODIUM STEARATE 
SORBITAN OLIVATE 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-403-251 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/06/2013
Labeler - Pure Source Inc. (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture(65121-403)

Revised: 6/2013
 
Pure Source Inc.