Australian Dream Back Pain Cream

Australian Dream Back Pain by

Drug Labeling and Warnings

Australian Dream Back Pain 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 BACK PAIN- 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.

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Australian Dream Back Pain Cream

Active ingredient

Histamine Dihydrochloride 0.050%

Purpose

Topical Analgesic

Uses

• For the temporary relief of minor aches and pains of muscles
  and joints associated with simple backache.

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 30°C).
• Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutita (Chamomile) Extract, Deionized Water, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6, Tumeric Extract, Zingiber Officinalis (Ginger) Extract

Questions or Comments?

Call 1.888.600.4642

Package Label

AUSTRALIAN DREAM BACK PAIN 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76017-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
WATER (UNII: 059QF0KO0R)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
REISHI (UNII: TKD8LH0X2Z)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
NIACIN (UNII: 2679MF687A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76017-200-04	119 g in 1 JAR; Type 0: Not a Combination Product	02/05/2017	12/03/2019
2	NDC: 76017-200-02	59 g in 1 JAR; Type 0: Not a Combination Product	02/05/2017	12/03/2019
3	NDC: 76017-200-09	266 g in 1 JAR; Type 0: Not a Combination Product	02/05/2017	12/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/10/2014	12/03/2019

Labeler - Nature's Health Connection (079549213)

Revised: 12/2019

Document Id: 98d290a3-8789-7153-e053-2a95a90ac03c

34390-5

Set id: bc5a71df-0ea0-4d7b-bd60-dd67ece7a1c7

Version: 6

Effective Time: 20191203

 

Nature's Health Connection