Johnson's® Baby Intense Moisture Cream

Johnsons Baby Intense Moisture by

Drug Labeling and Warnings

Johnsons Baby Intense Moisture by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JOHNSONS BABY INTENSE MOISTURE- dimethicone cream 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Johnson's® Baby Intense Moisture Cream

Drug Facts

Active ingredient

Dimethicone 2%

Purpose

Skin protectant

Uses

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

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

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed

Other information

• Store at room temperature

Inactive ingredients

Water, Glycerin, Glycine Soja (Soybean) Oil, Cetearyl Alcohol, Zea Mays (Corn) Starch, Phenoxyethanol, Cetearyl Glucoside, Carbomer, Fragrance, Hydrogenated Cottonseed Oil, Ethylhexylglycerin, Tocopheryl Acetate, Citric Acid, Sodium Hydroxide

Questions?

866-JNJ-BABY; Outside US & Canada, dial collect 215-273-8755

PRINCIPAL DISPLAY PANEL - 266 g Tube Carton

CLINICALLY
Mildness
PROVEN®

New!

Johnson's®
baby
intense
moisture cream
dimethicone – skin protectant

dry skin relief

24 hour moisture

Johnson & Johnson

Net Wt. 8 OZ (226 g)

JOHNSONS BABY INTENSE MOISTURE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-9202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Soybean Oil (UNII: 241ATL177A)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Starch, Corn (UNII: O8232NY3SJ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Hydrogenated Cottonseed Oil (UNII: Z82Y2C65EA)
Ethylhexylglycerin (UNII: 147D247K3P)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-9202-1	14 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2013	12/31/2019
2	NDC: 58232-9202-2	226 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2013	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/03/2013	12/31/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2019

Document Id: 34dc2796-ae03-4dfa-bd63-cc6c4136bb34

34390-5

Set id: f6d6899e-1c71-4d6d-b08b-9fc7e1cfb824

Version: 3

Effective Time: 20191231

 

Johnson & Johnson Consumer Inc.