Ropana Pain Relief Cream

Ropana Pain Relief Cream
SPL v2
SPL
SPL Set ID e0342aa3-ca80-40b7-bec6-1b33c4db398b
Route
TOPICAL
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (0.4 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Indian Frankincense Shea Butter Cetyl Alcohol Cyclomethicone 5 Dodecane Ethylhexylglycerin Chinese Cinnamon Oil Turmeric Ethyl Vanillin Glyceryl Monostearate Glycyrrhiza Glabra Helianthus Annuus Flowering Top Isopropyl Myristate Magnesium Sulfate, Unspecified Form Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Stearic Acid Trolamine Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-21

Description

Histamine DHCl 0.04%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Histamine DHCl 0.04%

Uses:

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

Warnings:

For external use only

Do Not Use
  • on damaged or broken skin.
Drug Facts

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Chldren under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Histamine DHCl 0.04%

Other Information:

Protct the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cinnamomum Cassia Oil, Curcuma Longa (Turmeric) Extract, Cyclopentasiloxane, Dodecane, Ethylhexylglycerin, Ethyl Vanillin, Glyceryl Stearate, Glycyrrhiza Glaba (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Xanthan Gum.

When Using This Product
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or 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. 


Structured Label Content

Uses:

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

Purpose

Topical Analgesic

Warnings:

For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Chldren under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Histamine DHCl 0.04%

Other Information:

Protct the product in this container from excessive heat and direct sun.

Inactive Ingredients: (Inactive ingredients:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cinnamomum Cassia Oil, Curcuma Longa (Turmeric) Extract, Cyclopentasiloxane, Dodecane, Ethylhexylglycerin, Ethyl Vanillin, Glyceryl Stearate, Glycyrrhiza Glaba (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Xanthan Gum.

When Using This Product (When using this product)
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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