Gentle Steps 496.000/496aa

Gentle Steps 496.000/496aa
SPL v5
SPL
SPL Set ID b7e867ea-663a-4da8-81c0-18f4c4fd565b
Route
TOPICAL
Published
Effective Date 2025-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (12 mg)
Inactive Ingredients
Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Oatmeal Benzyl Alcohol Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-18

Description

DAILY BABY LOTION with colloidal oatmeal SKIN PROTECTANT

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

DAILY BABY LOTION with colloidal oatmeal SKIN PROTECTANT

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

DAILY BABY LOTION

with colloidal oatmeal

SKIN PROTECTANT

Warnings

For external use only

Directions 
  • apply as needed
Do Not Use On
  • deep or punture wounds
  • animal bites
  • serious burns
Adverse Reaction

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

Active Ingredient

Dimethicone 1.2%

Other Information

store between 15°-30°C (59°-86°F)

Inactive Ingredients

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

When Using This Product

do not get into eyes

Principal Panel Display

Gentle Steps®

DAILY BABY LOTION

with colloidal oatmeal

SKIN PROTECTANT

Free From

Parabens, Phthalates & Fragrances

hypoallergenic

pediatrician tested

NET WT 8 Oz (227 g)

Stop Use and Ask A Doctor If
  • condition worsens
  • sympton last more than 7 days or clear 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 chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Claims

DAILY BABY LOTION

with colloidal oatmeal

SKIN PROTECTANT

Purpose

Skin protectant

Warnings

For external use only

Directions 
  • apply as needed
Do Not Use On (Do not use on)
  • deep or punture wounds
  • animal bites
  • serious burns
Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

Active Ingredient (Active ingredient)

Dimethicone 1.2%

Other Information (Other information)

store between 15°-30°C (59°-86°F)

Inactive Ingredients (inactive ingredients)

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

When Using This Product (When using this product)

do not get into eyes

Principal Panel Display (principal panel display)

Gentle Steps®

DAILY BABY LOTION

with colloidal oatmeal

SKIN PROTECTANT

Free From

Parabens, Phthalates & Fragrances

hypoallergenic

pediatrician tested

NET WT 8 Oz (227 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • sympton last more than 7 days or clear 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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