SPL v3
SPL
SPL Set ID 60e71d7b-ee69-4168-9ff7-ad9ce4e19ccb
Route
TOPICAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg) Dimethicone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Synthetic Beeswax Benzyl Alcohol Medium-chain Triglycerides Ceresin Coconut Oil Cod Liver Oil Glyceryl Monooleate Mineral Oil Paraffin Propylene Glycol Sorbitol Water

Identifiers & Packaging

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

Description

Active Ingredient  Dimethicone,  1%  Zinc Oxide,  10%

Purpose

Skin Protectant  Skin Protectant 


Medication Information

Purpose

Skin Protectant  Skin Protectant 

Description

Active Ingredient  Dimethicone,  1%  Zinc Oxide,  10%

Uses 
  • Helps treat and prevent diaper rash 
  • Protects chafed skin due to diaper rash and helps seal out wetness 
Purpose 

Skin Protectant 

Skin Protectant 

Warnings 

For external use only

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 clear up and occur again within a few days
Directions 
  • use after each diaper change. 
  • apply cream liberally to keep moisture away during night time or extended exposure to wetness. 
  • use as needed. 
Drug Facts 

Active Ingredient 

Dimethicone,  1% 

Zinc Oxide,  10%

Questions ? 

1800-222-1087

Other Information 

Store between 20°-25°C (68°-77°F)

Inactive Ingredients 

 Inactive Ingredients: Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Caprylic/Capric Triglyceride, Ceresin Wax (Ozokerite), Cocos Nucifera (Coconut) Oil, Cod Liver Oil (contains Vitamins A & D), Fragrance, Glyceryl Monooleate, Mineral Oil, Paraffin, Propylene Glycol, Sorbitol, Water (purified)

Keep Out of Reach of Children.

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

Principal Display Panel Tube 

CVS Diaper Rash Cream with A&D       NDC 51316-625-40

Dimethicone 1% Skin Protectant 

Zinc Oxide 10% Skin Protectant 

NET WT 4.0 oz ( 113g)

Principal Display Panel Carton 

CVS Diaper Rash Cream with A&D NDC 51316-625-40

Dimethicone 1% Skin Protectant

Zinc Oxide 10% Skin Protectant

NET WT 4.0 oz ( 113g)


Structured Label Content

Uses 
  • Helps treat and prevent diaper rash 
  • Protects chafed skin due to diaper rash and helps seal out wetness 
Purpose 

Skin Protectant 

Skin Protectant 

Warnings 

For external use only

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 clear up and occur again within a few days
Directions 
  • use after each diaper change. 
  • apply cream liberally to keep moisture away during night time or extended exposure to wetness. 
  • use as needed. 
Drug Facts 

Active Ingredient 

Dimethicone,  1% 

Zinc Oxide,  10%

Questions ? 

1800-222-1087

Other Information  (Other information )

Store between 20°-25°C (68°-77°F)

Inactive Ingredients  (Inactive ingredients )

 Inactive Ingredients: Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Caprylic/Capric Triglyceride, Ceresin Wax (Ozokerite), Cocos Nucifera (Coconut) Oil, Cod Liver Oil (contains Vitamins A & D), Fragrance, Glyceryl Monooleate, Mineral Oil, Paraffin, Propylene Glycol, Sorbitol, Water (purified)

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.

Principal Display Panel Tube  (Principal Display panel -Tube )

CVS Diaper Rash Cream with A&D       NDC 51316-625-40

Dimethicone 1% Skin Protectant 

Zinc Oxide 10% Skin Protectant 

NET WT 4.0 oz ( 113g)

Principal Display Panel Carton  (Principal Display Panel -Carton )

CVS Diaper Rash Cream with A&D NDC 51316-625-40

Dimethicone 1% Skin Protectant

Zinc Oxide 10% Skin Protectant

NET WT 4.0 oz ( 113g)


Advanced Ingredient Data


Raw Label Data

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