OTC Medication Information: Multi-Purpose Skin Protectant

MULTI-PURPOSE SKIN PROTECTANT- petrolatum and lanolin ointment
CVS Pharmacy

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.

Active Ingredients

Lanolin 15.5%

Petrolatum 53.4%

Uses

helps treat and prevent diaper rash, temporarily protects minor: cuts, scrapes and burns, temporarily protects and helps relieve chapped or cracked skin and lips, protects chafed skin due to diaper rash and helps seal out wetness

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

for skin protectant use: apply as needed

for diaper rash use: change wet and soiled diapers promptly, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

store between 20o C-25oC (68o F — 77oF)

Inactive ingredients

cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

Purpose

Diaper rash ointment, Skin protectant

Package label

package label
(click image for full-size original)

Tube label

Tube label
(click image for full-size original)

MULTI-PURPOSE SKIN PROTECTANT
a and d ointment ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-841
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 53.4 g in 100 g
LANOLIN (LANOLIN) LANOLIN 15.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE WAX 16.9 g in 100 g
PARAFFIN 2 g in 100 g
COD LIVER OIL 1.98 g in 100 g
MINERAL OIL 10 g in 100 g
CARROT SEED OIL 0.02 g in 100 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-841-01 42.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 07/20/2016
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
Unipack, Inc. 009248480 manufacture (59779-841)

Revised: 03/2018 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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