Histamine Dihydrochloride Pain Relieving Cream

Histamine Dihydrochloride Pain Relieving Cream
SPL v1
SPL
SPL Set ID 9eeea033-ae87-4d83-85d0-b8fa653a0806
Route
TOPICAL
Published
Effective Date 2025-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (0.05 g)
Inactive Ingredients
Water Cetostearyl Alcohol Emu Oil Glycerin Polyoxyl 20 Cetostearyl Ether Glucosamine Sulfate Dimethyl Sulfone Medium-chain Triglycerides Phenoxyethanol Cetyl Alcohol .alpha.-tocopherol Acetate Butylene Glycol Propylene Glycol Chamomile Rosemary Indian Frankincense Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20

Description

Histamine dihydrochloride 0.05% w/w

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Histamine dihydrochloride 0.05% w/w

Uses

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

Section 42229-5

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Packaging

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

Drug Facts

Active Ingredient

Histamine dihydrochloride 0.05% w/w

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 (Rosemarinus officinalis) 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.


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Pain reliever

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.

Packaging

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

Drug Facts

Active Ingredient (Active ingredient)

Histamine dihydrochloride 0.05% w/w

Other Information (Other information)

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

Inactive Ingredients: (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 (Rosemarinus officinalis) leaf extract, Indian frankincense (Boswellia serrata) extract, Ethylhexylglycerin.

Questions Or Comments? (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.


Advanced Ingredient Data


Raw Label Data

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