Australian Dream Pain Relieving Arthritis Cream

Australian Dream Pain Relieving Arthritis by

Drug Labeling and Warnings

Australian Dream Pain Relieving Arthritis by is a Otc medication manufactured, distributed, or labeled by Nature's Health Connection. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AUSTRALIAN DREAM PAIN RELIEVING ARTHRITIS- histamine dihydrochloride cream 
Nature's Health Connection

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.

----------

Australian Dream Pain Relieving Arthritis Cream

Drug Facts

Active Ingredient

Histamine dihydrochloride ...... 0.025%

Purpose

External Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.

Warnings

  • For external use only.
  • Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.

When using this product

  • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
  • do not bandage tightly or use a heating pad.

Stop use and ask a doctor if

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

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

  • For Use by Adults and Children over 12 years.
  • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
  • Children 12 years or younger consult a physician.

Other information

  • Store between 40°F and 86°F ( 4°C and 30C).
  • Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive ingredients

Deionized Water, Emu Oil, Butylene Glycol, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Oil, Polyacrylamide, Sodium Polyacrylate, C13-14 Isoparafiin, Ethylhexyl Stearate, Glucosamine Sulfate, Chondroitin Sulfate, Tocopheryl Acetate (Vitamin-E), Trideceth-6, Laureth-7, Tetrasodium EDTA, Potassium Sorbate, Methylisothiazolinone

Questions or Comments? Call 1.888.600.4642

Distributed by: Nature's Health Connection ® Inc.
PO Box 609, Campton, KY 41301 www.AustralianDream.com

Australian Dream

Pain Relieving Arthritis Cream

Net Wt. 4 oz (119g)

Australian Dream 4oz

AUSTRALIAN DREAM PAIN RELIEVING ARTHRITIS 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76017-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
WATER (UNII: 059QF0KO0R)  
EMU OIL (UNII: 344821WD61)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
LAURETH-7 (UNII: Z95S6G8201)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76017-100-09266 g in 1 JAR; Type 0: Not a Combination Product02/07/201712/03/2019
2NDC: 76017-100-04119 g in 1 JAR; Type 0: Not a Combination Product02/07/201712/03/2019
3NDC: 76017-100-0259 g in 1 JAR; Type 0: Not a Combination Product02/07/201712/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/09/201112/03/2019
Labeler - Nature's Health Connection (079549213)

Revised: 12/2019
 
Nature's Health Connection