SPL v9
SPL
SPL Set ID c5d52f13-a649-9579-e053-2a95a90a062c
Routes
NASAL TOPICAL
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (15.21 mg) Zinc Oxide (18.9 g) Salicylic Acid (10.4 g)
Inactive Ingredients
Eucalyptus Oil Water Sea Salt Propolis Wax Glycerin Butyrospermum Parkii (shea) Butter Unsaponifiables Jojoba Oil .alpha.-tocopherol Acetate Panthenol Coco-caprylate/caprate Magnesium Sulfate Anhydrous Aloe Vera Leaf Argan Oil Dicaprylyl Carbonate Sodium Stearoyl Glutamate Glyceryl Citrate Olea Europaea (olive) Oil Unsaponifiables Physalis Angulata White Wax Sesame Oil Xanthan Gum Hydrolyzed Jojoba Esters (potassium Salts) Polyglyceryl-3 Oleate Polyglyceryl-2 Dipolyhydroxystearate Polyglyceryl-3 Diisostearate Caprylic/capric/lauric Triglyceride Helianthus Annuus Seed Wax Polyglyceryl-4 Isostearate Polyglycerin-3 Palm Oil Palm Kernel Oil Coconut Oil Canola Oil Olea Europaea Flower Honey .alpha.-tocopherol Acetate, D- Royal Jelly Apis Mellifera Venom Hydroxyethyl Cellulose, Unspecified Beet Caprylic Acid Rosa Multiflora Fruit Hyaluronic Acid Actinidia Polygama Fruit Xylitol Tea Tree Oil Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-29

Description

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Aftersun

Warnings

For external use only. Flammable. Keep away from heat or flame

Sos Cream

SOS Cream

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Propolis Nasal

Sunscreen Spf50

Diaper Rash Cream

Diaper Rash Cream50 mL NDC: 82123-005

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Acne Control Serum

30 ml NDC:​ 82123-009

Propolis Nasal Plus

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Sunscreen for Face Spf50

Sunscreen for Kids Spf50


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Aftersun

Warnings

For external use only. Flammable. Keep away from heat or flame

Sos Cream (SOS Cream)

SOS Cream

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Propolis Nasal

Sunscreen Spf50 (Sunscreen SPF50)

Diaper Rash Cream

Diaper Rash Cream50 mL NDC: 82123-005

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Acne Control Serum

30 ml NDC:​ 82123-009

Propolis Nasal Plus

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Sunscreen for Face Spf50 (Sunscreen for face SPF50)

Sunscreen for Kids Spf50 (Sunscreen for kids SPF50)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)