Publix 619.003/619ac Rev 2

Publix 619.003/619ac Rev 2
SPL v18
SPL
SPL Set ID 28ac9de4-2a63-4839-bed5-9bcc59ebeb2a
Route
TOPICAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (13 mg)
Inactive Ingredients
Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oatmeal Benzyl Alcohol Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1993-03-19 Until 2025-08-08

Description

P daily moisturizing FRAGRANCE-FREE LOTION

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

P daily moisturizing FRAGRANCE-FREE LOTION

Uses
  • helps prevent and temporarily protects chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Claims

P

daily moisturizing

FRAGRANCE-FREE LOTION

Warnings

For external use only

Directions

apply as needed

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Adverse Reaction

Distributed by Publix Super Markets, Inc

3300 Publix Corporate Parkway, Lakeland, FL 33811

1-888-267-3037 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

Publix ®

SCAN HERE FOR MORE INFORMATION

Active Ingredient

Dimethicone 1.3%

Inactive Ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride

When Using This Product
  • do not get into eyes
Principal Display Panel

P

daily moisturizing

FRAGRANCE-FREE LOTION

NATURAL COLLOIDAL OATMEAL

PROTECTS AND RELIEVES DRY SKIN

DERMATOLOGIST TESTED

PARABEN-FREE

18 FL OZ (1.12 PT) 532 mL

Stop Use and Ask A Doctor If
  • condition worsens 
  • symptoms last more than 7 days or cleat up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent and temporarily protects chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Claims

P

daily moisturizing

FRAGRANCE-FREE LOTION

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Adverse Reaction

Distributed by Publix Super Markets, Inc

3300 Publix Corporate Parkway, Lakeland, FL 33811

1-888-267-3037 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

Publix ®

SCAN HERE FOR MORE INFORMATION

Active Ingredient (Active ingredient)

Dimethicone 1.3%

Inactive Ingredients (Inactive ingredients)

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride

When Using This Product (When using this product)
  • do not get into eyes
Principal Display Panel (principal display panel)

P

daily moisturizing

FRAGRANCE-FREE LOTION

NATURAL COLLOIDAL OATMEAL

PROTECTS AND RELIEVES DRY SKIN

DERMATOLOGIST TESTED

PARABEN-FREE

18 FL OZ (1.12 PT) 532 mL

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens 
  • symptoms last more than 7 days or cleat up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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