PAIN RELIEVING CREAM- histamine dihydrochloride cream

Pain Relieving Cream by

Drug Labeling and Warnings

Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Mediapower, Inc. DBA Dr Newton's And Naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Histamine dihydrochloride 0.05% w/w

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache  arthritis strains bruises sprains

Warnings

For external use only

Do not use on wounds or damaged skin  if you are allergic to ingredients in this product

When using this product avoid contact with the eyes. If product gets into the 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, or if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days

If pregnant or breastfeeding, 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

adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a physician

Other information

store between 68° and 77° F (20° and 25° C)

Inactive ingredients:

Water, Cetearyl alcohol, Emu oil, Glycerin, Ceteareth-20, Glucosamine sulfate, Dimethyl sulfone, Caprylic/capric triglyceride, Phenoxyethanol, Cetyl alcohol, Tocopherol acetate, Butylene glycol, Propylene glycol, Chamomile (Chamomilla recutita) flower extract, Rosemary (Rosemarinusofficinalis) leaf extract, Indian frankincense (Boswellia serrata) extract, Ethylhexylglycerin.

Questions or comments?

+1-866-788-5951

You may also report serious side effects to this phone number.

Mon-Fri 8:00 A.M. - 6:00 P.M.

SPL UNCLASSIFIED SECTION

DR. NEWTON'S™ NATURALS

Temporary Pain Relief

Moisturizing Cream

Odorless, Greaseless, Stainless

Distributed by
Dr. Newton's Naturals
26 Thomas Drive,
Westbrook, ME 04092

To re-order call 800-280-5590

MADE IN USA

www.drnewtons.com

Packaging

INGREDIENTS AND APPEARANCE

PAIN RELIEVING CREAM 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85063-101
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
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHAMOMILE (UNII: FGL3685T2X)
ROSEMARY (UNII: IJ67X351P9)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85063-101-85	85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/20/2025

Labeler - Mediapower, Inc. DBA Dr Newton's And Naturals (883666190)