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

Purpose

Skin protectant

Description

P daily moisturizing FRAGRANCE-FREE LOTION


Medication Information

Warnings

For external use only

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

Skin protectant

Directions

apply as needed

Inactive Ingredients

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

Description

P daily moisturizing FRAGRANCE-FREE LOTION

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

Claims

P

daily moisturizing

FRAGRANCE-FREE LOTION

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%

When Using This Product
  • do not get into eyes
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

Warnings

For external use only

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

Skin protectant

Directions

apply as needed

Inactive Ingredients (Inactive ingredients)

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

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

Claims

P

daily moisturizing

FRAGRANCE-FREE LOTION

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%

When Using This Product (When using this product)
  • do not get into eyes
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

All Sections (JSON)