smith amish eczema cream (2oz) - 72609-704-02; smith amish eczema cream (4oz) - 72609-704-04

smith amish eczema cream (2oz) - 72609-704-02; smith amish eczema cream (4oz) - 72609-704-04
SPL v5
SPL
SPL Set ID 20c4bc16-ba20-47ec-e063-6394a90a8b4e
Route
topical
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (1.25 g)
Inactive Ingredients
almond oil jojoba oil glyceryl monostearate peppermint oil .alpha.-tocopherol arnica montana whole cetyl palmitate sodium citrate stearic acid tea tree oil water glycerin phenoxyethanol panthenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-28

Purpose

Skin Protectant

Description

Colloidal Oatmeal 2.0%


Medication Information

Warnings
  • For external use only
  • When using this product do not get into eyes
Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

Purpose

Skin Protectant

Directions

Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.

Other Information

Protect from excessive heat

Store at 20-25 oC (68-77F)

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Description

Colloidal Oatmeal 2.0%

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

Label

Smith Amish Eczema Cream (72609-704-02)

Deep Moisturizing Cream

for sensitive, distressed, dry, scaly skin

Clean Fresh Scent

Easily Absorbed and Non-Greasy

Net wt. 2oz (59g)

Section 42229-5

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Section 50566-9
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Drug Facts

Colloidal Oatmeal 2.0%

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
  • When using this product do not get into eyes
Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

Purpose

Skin Protectant

Directions

Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.

Other Information (Other information)

Protect from excessive heat

Store at 20-25 oC (68-77F)

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

Label

Smith Amish Eczema Cream (72609-704-02)

Deep Moisturizing Cream

for sensitive, distressed, dry, scaly skin

Clean Fresh Scent

Easily Absorbed and Non-Greasy

Net wt. 2oz (59g)

Section 42229-5 (42229-5)

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Section 50566-9 (50566-9)
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Drug Facts

Colloidal Oatmeal 2.0%

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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