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NDC 49035-0822-01 Medicated Body Extra Strength 2.26 g/283g Details

Medicated Body Extra Strength 2.26 g/283g

Medicated Body Extra Strength is a TOPICAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by Walmart Stores Inc. The primary component is MENTHOL.

Product Information

NDC	49035-0822
Product ID	49035-822_b0786418-7b29-d316-e053-2995a90a3ab5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Medicated Body Extra Strength
Proprietary Name Suffix	Powder
Non-Proprietary Name	MENTHOL 0.80%
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	TOPICAL
Active Ingredient Strength	2.26
Active Ingredient Units	g/283g
Substance Name	MENTHOL
Labeler Name	Walmart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0822-01 (49035082201)

Pricing Information	N/A
NDC Package Code	49035-822-01
Billing NDC	49035082201
Package	283 g in 1 BOTTLE (49035-822-01)
Marketing Start Date	2020-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b0786418-7b28-d316-e053-2995a90a3ab5 Details

Drug Facts Active Ingredients

Menthol 0.80 %

Purpose

External Analgesic

Uses

for the temporary relief of the pain and itch associated with

minor cuts
scrapes
sunburn
insect bites
prickly heat
rashes
minor burns
minor skin irritations
dries the oozing of poison ivy, oak and sumac.

Warnings

For external use only

When usin this product

Avoid contact with eyes. Not for genital area.

Stop use and ask a doctor if

condition worsens
Redness, irritation, swelling or pain persists or increases
symptoms do not get better within 7 days or clear up and occur again within a few days

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 2 years and older, apply freely up to 3 or 4 times daily
Children under 2 years: consult a physician
for best results, dry skin thoroughly before use

Inactive Ingredients

Acacia, seyal gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, Thymol, tricalcium phosphate, Zea mays (corn) starch, zinc oxide, zinc stearate.

Medicated Body Powder Extra Strength

NDC 49035-295-10

equate™

Compare to GoldBond® Medicated Body Powder Active Ingredients

Medicated Body Powder

4 X Relief

Relieves Itcing
Cools Skin
Absorbs Moisture
Helps Protect skin

Menthol 0.15%

NET WT 10 OZ (283g)

Medicated Body Powder

Satisfaction guarenteed- or we'll replace it or give you your money back.

For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

DISTRIBUTED BY:

Wal-Mart Stores, Inc.,

Bentonville, AR 72716

PRODUCT OF IINDIA

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Gold Bond® Medicated body Powder.

INGREDIENTS AND APPEARANCE

MEDICATED BODY EXTRA STRENGTH POWDER

menthol 0.80% powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-822
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.26 g in 283 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ACACIA (UNII: 5C5403N26O)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)
ZINC OXIDE (UNII: SOI2LOH54Z)
ZEA MAYS WHOLE (UNII: 1G5HNE09V8)
ACACIA SEYAL WHOLE (UNII: 0H7YR6DN6P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-822-01	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2020

Labeler - Walmart Stores Inc (051957769)

Revised: 9/2020

Document Id: b0786418-7b29-d316-e053-2995a90a3ab5

Set id: b0786418-7b28-d316-e053-2995a90a3ab5

Version: 1

Effective Time: 20200929