OTC Medication Information: Baby

BABY- talc powder
Walgreen Company

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 ingredient

Talc 100%

Purpose

Skin Protectant

Uses
Keeps skin soft, fresh & comfortable.

Warnings

For external use only.

Keep out of reach of children

Close tightly after use.

Do not use on broken skin.

Avoid contact with eyes.

Keep powder away from child’s face to avoid inhalation, which can cause breathing problems.

Directions

Shake powder into your hand and smooth onto skin.

Storage

Store in a cool, dry place.

Inactive ingredient

Fragrance

Package/Label Principal Display Panel

Baby Powder

Keeps skin soft, fresh & comfortable

Clinically Tested

NET WT 4 OZ (113 g)

label
(click image for full-size original)

BABY
talc powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0901
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALC (TALC) TALC 100 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FRAGRANCE CLEAN ORC0600327 0.1 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0901-04 113 g in 1 BOTTLE None
2 NDC:0363-0901-15 425 g in 1 BOTTLE None
3 NDC:0363-0901-22 623 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 07/17/2014
Labeler — Walgreen Company (008965063)
Registrant — Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture (0363-0901)

Revised: 08/2020 Walgreen Company

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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