SPL v1
SPL
SPL Set ID 290692c0-54d9-d401-e063-6294a90a705a
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (12 [hp_X]) Matricaria Recutita (30 [hp_X]) Arnica Montana Root
Inactive Ingredients
Sorbic Acid Sodium Benzoate Water Xanthan Gum Potassium Sorbate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-21

Description

Arnica, radix 30X HPUS 3.33 % Calcarea phosphorica 12XHPUS 3.33 % Chamomilla 12X HPUS 3.33 %


Medication Information

Warnings and Precautions

Counsult a Physician if

  • symptoms persist for more than 72 hours or worsen
  • irritation, pain, or redness persits or worsen
  • rash or fever develops
  • swelling increases

Description

Arnica, radix 30X HPUS 3.33 % Calcarea phosphorica 12XHPUS 3.33 % Chamomilla 12X HPUS 3.33 %

Section 50565-1

Keep this and all medication out of the reach of children.

In case of accidental overdose, contact a medical professional or a Poison Control immidiately.

Section 51727-6
  • Aqua (Purified Water)
  • Potassium Sorbate NF
  • Sodium Benzoate NF
  • Sorbic Acid NF
  • Vegetable Glycerin USP
  • Xantham Gum NF

Section 51945-4

DR. Talbot's

Soothing Gel

Naturally Inspired

Soothes sore Gums

with Chamomile

Benzocaine/Belladonna free

Section 53413-1

Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT

Section 55105-1

Temporarily relieves sore gums, pain, and irritability due to oral discomfort.

Section 55106-9
  • Arnica, radix 30X HPUS 3.33 %
  • Calcarea phosphorica 12XHPUS 3.33 %
  • Chamomilla 12X HPUS 3.33 %

Section 59845-8
  • Wash hands before use
  • Cut open tip of tube on score mark
  • Use your fingertip or cotton applicator to gently apply a small pea-sized maount of Dr. Talbot's Soothing Gel to the affected area 15 miniutes as neccassary or as directed by a physician or health provider

Section 60561-8

Tamper evident - Do not use if tube tip is cut prior to opening


Structured Label Content

Warnings and Precautions (34071-1)

Counsult a Physician if

  • symptoms persist for more than 72 hours or worsen
  • irritation, pain, or redness persits or worsen
  • rash or fever develops
  • swelling increases

Section 50565-1 (50565-1)

Keep this and all medication out of the reach of children.

In case of accidental overdose, contact a medical professional or a Poison Control immidiately.

Section 51727-6 (51727-6)
  • Aqua (Purified Water)
  • Potassium Sorbate NF
  • Sodium Benzoate NF
  • Sorbic Acid NF
  • Vegetable Glycerin USP
  • Xantham Gum NF

Section 51945-4 (51945-4)

DR. Talbot's

Soothing Gel

Naturally Inspired

Soothes sore Gums

with Chamomile

Benzocaine/Belladonna free

Section 53413-1 (53413-1)

Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT

Section 55105-1 (55105-1)

Temporarily relieves sore gums, pain, and irritability due to oral discomfort.

Section 55106-9 (55106-9)
  • Arnica, radix 30X HPUS 3.33 %
  • Calcarea phosphorica 12XHPUS 3.33 %
  • Chamomilla 12X HPUS 3.33 %

Section 59845-8 (59845-8)
  • Wash hands before use
  • Cut open tip of tube on score mark
  • Use your fingertip or cotton applicator to gently apply a small pea-sized maount of Dr. Talbot's Soothing Gel to the affected area 15 miniutes as neccassary or as directed by a physician or health provider

Section 60561-8 (60561-8)

Tamper evident - Do not use if tube tip is cut prior to opening


Advanced Ingredient Data


Raw Label Data

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