Wild Horse 777 Oral Spray

Wild Horse 777 Oral Spray
SPL v4
SPL
SPL Set ID b0b517bb-969f-0c65-e053-2995a90a48b1
Route
TOPICAL
Published
Effective Date 2020-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (6 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-02

Description

Phenol 0.6%

Purpose

Anesthetic/Analgesic


Medication Information

Purpose

Anesthetic/Analgesic

Description

Phenol 0.6%

Uses

Temporarily relieves sore throate pain and minor mouth irritation.

Purpose:

Anesthetic/Analgesic

Warnings

- Use only as directed. 

- The use of this container by more than one person may spread infection.

Directions

- 12 years old - adult:3 sprays.

- 6-12 years old: 2 sprays.

- 3-6 years old: 1 spray.

- Children under age 3:1 spray. Consult a physician.

- User should be in an upright position.

- To use, remove cap, depress the pump completely to spray directly into mouth and throat.

- Each spray is followed by a small sip of lukewarm water (<100 °F).

- Swish water thoroughly for a few seconds, then swallow.

- Day 1: every 3-4 hours.

- Day 2: every 3-4 hours.

- Day 3: twice a day.

- Day 4: at bedtime.

- Day 5: at bedtime.

- Day 6-9: skip.

- Day 10: at bedtime (final dose).

Other Information

- Store and use at room temperature.

- Inspect the bottle for integrity. 

- Do not use if the safety seal is torn or broken.

Package Labeling:

Active Ingredient:

Phenol 0.6%

Inactive Ingredient:

Purified mineral water

Questions and Comments:

1-800-880-1993 www.wildhorse777.net

Stop Use and Ask A Doctor

- if you experience any discomfort while using this product.

- In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

If Pregnant Or Breastfeeding,

consult a health care professional before use.


Structured Label Content

Uses

Temporarily relieves sore throate pain and minor mouth irritation.

Purpose:

Anesthetic/Analgesic

Warnings

- Use only as directed. 

- The use of this container by more than one person may spread infection.

Directions

- 12 years old - adult:3 sprays.

- 6-12 years old: 2 sprays.

- 3-6 years old: 1 spray.

- Children under age 3:1 spray. Consult a physician.

- User should be in an upright position.

- To use, remove cap, depress the pump completely to spray directly into mouth and throat.

- Each spray is followed by a small sip of lukewarm water (<100 °F).

- Swish water thoroughly for a few seconds, then swallow.

- Day 1: every 3-4 hours.

- Day 2: every 3-4 hours.

- Day 3: twice a day.

- Day 4: at bedtime.

- Day 5: at bedtime.

- Day 6-9: skip.

- Day 10: at bedtime (final dose).

Other Information

- Store and use at room temperature.

- Inspect the bottle for integrity. 

- Do not use if the safety seal is torn or broken.

Package Labeling:

Active Ingredient:

Phenol 0.6%

Inactive Ingredient:

Purified mineral water

Questions and Comments:

1-800-880-1993 www.wildhorse777.net

Stop Use and Ask A Doctor (Stop use and ask a doctor)

- if you experience any discomfort while using this product.

- In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

consult a health care professional before use.


Advanced Ingredient Data


Raw Label Data

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