OTC Medication Information: Natures Choice Baby

NATURES CHOICE BABY- talc powder
Unipack, 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.

Active Ingredient

Talc 99%

Purpose

Skin Protectant

Uses

It helps to absorb excess moisture, keeps the baby’s skin dry and soft for ultimate comfort.

Warnings

  • Keep out of reach of children.
  • For external use only.
  • Avoid contact with eyes, discontinue use if irritation persists.
  • Avoid ingestion or accidental inhalation by baby. Seek professional assistance if needed.

Directions

After changing diapers and after every bath dry baby’s skin thoroughly and apply liberally as needed.

Inactive Ingredient

Fragrance

Package/Label Principal Display Panel

Natures Choice Baby Powder

Velvety Soft

NET WT 22 OZ (624 g)

LABEL
(click image for full-size original)
NATURES CHOICE BABY
talc powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALC (TALC) TALC 99 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43749-112-05 50 g in 1 BOTTLE None
2 NDC:43749-112-06 100 g in 1 BOTTLE None
3 NDC:43749-112-07 113 g in 1 BOTTLE None
4 NDC:43749-112-09 116 g in 1 BOTTLE None
5 NDC:43749-112-10 368 g in 1 BOTTLE None
6 NDC:43749-112-11 396 g in 1 BOTTLE None
7 NDC:43749-112-14 424 g in 1 BOTTLE None
8 NDC:43749-112-15 624 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 06/07/2016
Labeler — Unipack, Inc. (009248480)
Registrant — Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture (43749-112)

Revised: 06/2016 Unipack, Inc.

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.

Medication Sections

Medication Information by RSS

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.

Terms of Use | Copyright © 2021. All Rights Reserved.