462a2822-b2e9-4d63-8706-0755c2ca0a21

SPL v1
SPL
SPL Set ID 462a2822-b2e9-4d63-8706-0755c2ca0a21
Route
topical
Published
Effective Date 2025-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
brazilian rosewood oil (0.35 g) calendula officinalis flowering top (0.95 g) english lavender oil (0.75 g) matricaria chamomilla (0.6 g) peppermint (0.8 g) hyaluronic acid (0.1 g)
Inactive Ingredients
aloe vera leaf polysaccharides water carbomer homopolymer, unspecified type ethylhexylglycerin glycerin phenoxyethanol sodium hydroxide

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2025-05-23
Purpose

Relaxing, cooling, anti-inflammatory, soothing, relieving

Description

Aniba Rossadora 0.35 % Calendula Officinalis 0.95 % Lavandula Officialls 0.75 % Matricaria Chamomilla 0.6 % Mentha Piperita 0.8 % Sodium Hyaluronate 0.1 %

Medication Information

Warnings

For external use only.

  • Not suitable for epileptics
  • Not suitable for people with uncontrolled hyper-tension. 
  • Not recommended during pregnancy and lactation
  • Not suitable for individuals with known sensitivity to any of the ingredients. 
  • Avoid contact with eyes.
Uses

Cooling down the skin

Purpose

Relaxing, cooling, anti-inflammatory, soothing, relieving

Directions

Shake well before use

Adults: Apply up to three times per day as needed

Children: Use conservatively for children younger than two years

Other Information

Store at or below 77⁰ F/25⁰C

Do not use if seal is broken.

product the product in this container from excessive heat and direact sun

Inactive Ingredients

Aloe Vera, Aqua, Carbomer, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide

Description

Aniba Rossadora 0.35 % Calendula Officinalis 0.95 % Lavandula Officialls 0.75 % Matricaria Chamomilla 0.6 % Mentha Piperita 0.8 % Sodium Hyaluronate 0.1 %

Section 50565-1

Drug Facts

Product Label

Active Ingredients

Aniba Rossadora 0.35 %

Calendula Officinalis 0.95 %

Lavandula Officialls 0.75 %

Matricaria Chamomilla 0.6 %

Mentha Piperita 0.8 %

Sodium Hyaluronate 0.1 %

Structured Label Content

Warnings

For external use only.

  • Not suitable for epileptics
  • Not suitable for people with uncontrolled hyper-tension. 
  • Not recommended during pregnancy and lactation
  • Not suitable for individuals with known sensitivity to any of the ingredients. 
  • Avoid contact with eyes.
Uses

Cooling down the skin

Purpose

Relaxing, cooling, anti-inflammatory, soothing, relieving

Directions

Shake well before use

Adults: Apply up to three times per day as needed

Children: Use conservatively for children younger than two years

Other Information (Other information)

Store at or below 77⁰ F/25⁰C

Do not use if seal is broken.

product the product in this container from excessive heat and direact sun

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Aqua, Carbomer, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredients (Active ingredients)

Aniba Rossadora 0.35 %

Calendula Officinalis 0.95 %

Lavandula Officialls 0.75 %

Matricaria Chamomilla 0.6 %

Mentha Piperita 0.8 %

Sodium Hyaluronate 0.1 %

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:03.798496 · Updated: 2026-03-14T23:17:24.422888