SPL v1
SPL
SPL Set ID 2c2b328d-8283-d28d-e063-6294a90a5bd9
Route
TOPICAL
Published
Effective Date 2025-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-21

Description

Arnica Montana, radix 30X HPUS 3.33% Calcarea Phosphorica 12 X HPUS 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 persists or worsens
  • rash or fever develops
  • swelling increases

Dosage and Administration

Directions

  • Wash hands before use
  • Cut open tip of tube on score mark
  • Use your fingertip or cotton applicator to gently apply a small pea-size amount of Dr. Talbot's Soothing gel to the affected area every 15 minitues as neccessary or as directed by a physician or healthcare provider

Description

Arnica Montana, radix 30X HPUS 3.33% Calcarea Phosphorica 12 X HPUS 3.33% Chamomilla 12X HPUS 3.33%

Section 50565-1

Keep this and all medications out of the reach of children

​​in case of accidental overdose, contact a medical perffessional or a Poision Control Center 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

NDC 70797-240-01 Bonus!!

SAFE TO SWALLOW Gum-eez-teether

Dr Talbot's

Soothing Gel 0m+

Naturally

Inspired

Soothes

sore gums

With

Chamomile

Benzocaine

/Belledonna

free

Section 53413-1

Questions & comments?

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

Section 55105-1

Purpose

  • soregums
  • sensitive gums
  • pain ssociated with irritability

Section 55106-9
  • Arnica Montana, radix 30X HPUS 3.33%

  • Calcarea Phosphorica 12 X HPUS 3.33%

  • Chamomilla 12X HPUS 3.33%

Section 60561-8

Other information

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


Structured Label Content

Dosage and Administration (34068-7)

Directions

  • Wash hands before use
  • Cut open tip of tube on score mark
  • Use your fingertip or cotton applicator to gently apply a small pea-size amount of Dr. Talbot's Soothing gel to the affected area every 15 minitues as neccessary or as directed by a physician or healthcare provider

Warnings and Precautions (34071-1)

Counsult a Physician if

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

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children

​​in case of accidental overdose, contact a medical perffessional or a Poision Control Center 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)

NDC 70797-240-01 Bonus!!

SAFE TO SWALLOW Gum-eez-teether

Dr Talbot's

Soothing Gel 0m+

Naturally

Inspired

Soothes

sore gums

With

Chamomile

Benzocaine

/Belledonna

free

Section 53413-1 (53413-1)

Questions & comments?

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

Section 55105-1 (55105-1)

Purpose

  • soregums
  • sensitive gums
  • pain ssociated with irritability

Section 55106-9 (55106-9)
  • Arnica Montana, radix 30X HPUS 3.33%

  • Calcarea Phosphorica 12 X HPUS 3.33%

  • Chamomilla 12X HPUS 3.33%

Section 60561-8 (60561-8)

Other information

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


Advanced Ingredient Data


Raw Label Data

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